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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA/FDA Joint Regulatory Conference

Ensuring Product Quality in an Era of Innovative Therapies
Sep 11 - Sep 13, 2017 |
Sep 13, 2017 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
Exhibition: September 11-12
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For more than 25 years, the U.S. FDA and PDA have collaborated on the PDA/FDA Joint Regulatory Conference, a premier pharmaceutical manufacturing industry event where participants have the unique opportunity to engage directly with FDA representatives and industry experts. Attendees return to this popular Conference year after year to hear FDA regulators provide updates on current efforts affecting the development of global regulatory strategies, and industry experts present case studies illustrating how they use global strategies to improve the quality of medical products.

Built around the exciting theme, “Ensuring Product Quality in an Era of Innovative Therapies,” this year’s Conference agenda will highlight the advanced biomedical innovations leading to safer and more effective therapies for patients. Plenary, concurrent, breakfast and interest group sessions will provide new perspectives and best practices on a variety of important industry topics, including:

  • Breakthrough Therapies
  • Case Studies for Quality
  • Center Updates
  • Clinically Relevant Specifications
  • Continuous Manufacturing
  • Compliance Updates
  • Continuous Verification and Validation
  • Contract Manufacturing Organizations
  • Customer Complaint Reviews and Trending
  • Drug Shortages
  • Global Harmonization Initiatives
  • "Fishbowl" Role Play
  • Human Factors Investigations
  • Lifecycle Management
  • Manufacturing of the Future with Submissions
  • Maturity of Quality Systems
  • Patient Perspective
  • Quality Metrics/Quality Culture
  • Quality Systems
  • Prescription Drug User Fee Act
  • Product Quality
  • Quality Risk Management Systems
  • Quality Submissions
  • Regulatory Challenges and Opportunities
  • Risk-Based Control Strategies
  • Supply Chain

Join nearly 1,000 of your peers and engage directly with regulatory and industry experts at this signature event exploring the effective delivery of future medicines and innovative therapies.

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: moir@pda.org

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: hall@pda.org

Monday, September 11, 2017

7:00 a.m. – 5:30 p.m.
Registration Open

7:30 a.m. – 8:30 a.m.
Continental Breakfast

8:00 a.m.-10:00 a.m.
P1: Welcome Remarks and Opening Plenary
Moderator: David J. Cummings, MPH, Lead Interdisciplinary Scientist, OPQ, FDA

Session Description: In the opening session, you will hear from FDA leadership about FDA's role in making America's biomedical industry a global leader and how public health crises have led Congress to establish standards for safety and effectiveness. FDA's Peter Marks, MD, PhD, will address how FDA continues to strive to accelerate access to innovative medical product development, focusing on orphan drugs, combination products, novel agents and advanced therapies, including cellular and gene therapy products. We will also hear an Industry representative talk about how their organization is advancing medical products through technological innovation in in biology and engineering. In this session, you will learn about advances in the area of precision medicine, considerations from the patient perspective, efforts to advance science and engineering in the area of medical products. You will also hear about the need to hire and retain highly qualified scientific and regulatory experts.

8:00 a.m. – 8:10 a.m.
Martin VanTrieste, Chair, PDA Board of Directors
Richard M. Johnson, President and CEO, PDA

8:10 a.m. – 8:30 a.m.
David J. Cummings, MPH, Lead Interdisciplinary Scientist, OPQ, FDA and Co-Chair, 2017 PDA/FDA Joint Regulatory Conference Program Planning Committee
Maria Guazzaroni Jacobs, PhD, Director, Quality and Regulatory Policy, Pfizer, Inc.and Co-Chair, 2017 PDA/FDA Joint Regulatory Conference Program Planning Committee

8:30 a.m. – 9:00 a.m.
FDA Perspective on Medical Product Innovation
Peter W. Marks, MD, PhD,
Director, Center for Biologics Evaluation and Research, FDA

9:00 a.m. – 9:30 a.m.
Industry Perspective on Medical Product Innovation
Industry Representative Invited

9:30 a.m. – 10:00 a.m.
Questions and Answers/Discussion

9:45 a.m. – 8:00 p.m. 
Exhibit Area Open

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area

10:45 a.m. – 12:15 p.m.
P2: Current Quality Challenges for Pharmaceutical Executives
Moderators: Richard L. Friedman, MS, Deputy Director, OMQ, CDER, FDA

Session Description: As the biopharmaceutical industry continues to evolve, major challenges associated with globalization and complexity of the supply chain emerge. In addition, companies now face internal pressures related to the cost of medicines, dealing with various global regulatory frameworks and changing expectations in evolving healthcare systems. The challenges have led an industry drive to adopt new business and quality technologies and to pursue partnerships with global regulators to help companies understand and facilitate implementation of changing regulations. This session will focus on major challenges that quality professionals should be aware as they interact with executives at their firms, how ensuring quality can play a part in overcoming those challenges and the crucial role of the executive in driving quality within the company.

10:45 a.m. – 11:15 a.m.
Investing in Quality to Meet Business Objectives
Guy Villax,
CEO, Hovione  

11:15 a.m. – 11:45 a.m.
Business Challenges and the Quality Imperative
John R. Pinion, II,
Chief Quality Operations Officer, Executive Vice President, Bioanalytical Research and Development, Ultragenyx Pharmaceutical

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

12:15 p.m. – 1:30 p.m.
Lunch on your own (Exhibit Area Closed) - A listing of local restaurants is available at the PDA registration desk

1:30 p.m. – 3:00 p.m.
Concurrent Sessions

Product Quality

A1: Data Integrity
Moderator: Renée Kyro, MBA, Director, Quality Assurance Compliance Program Management, Quality Assurance, AbbVie

Session Description: The integrity and accuracy of data generated in clinical trials and during testing and manufacturing of finished products is critical to making sound scientific-based decisions on the efficacy and safety of drugs that ultimately reach our most important customer, the patient. In this session, we will learn about the current and continuing data integrity issues facing the industry, the consequences to the supply chain and patients when data integrity is compromised and how to prevent data integrity issues from impacting your global supply chain.

1:30 p.m. – 2:00 p.m.
Regulatory Perspective on Data Integrity
Carmelo Rosa, Director Division, International Drug Quality, CDER, FDA 

2:00 p.m. – 2:30 p.m.
Industry Perspective on Data Integrity
Cormac Dalton, PhD, Director, Compliance, Supply Chain and Commercial Quality, AbbVie

2:30 p.m. – 3:00 p.m.
Panel Discussion
Cormac Dalton, PhD, Director, Compliance, Supply Chain and Commercial Quality, AbbVie
U.S. FDA ORA Representative Invited
Carmelo Rosa, 
Director Division, International Drug Quality, CDER, FDA

Lifecycle

B1: Quality Systems: Maturity Models and Continuous Improvement
Moderator: Jacqueline Kunzler, MBA, PhD, Senior Vice President, Global Quality, Baxter Healthcare Corporation

Session Description: All of us are committed to continuous improvement, but how should it be carried out? We will discuss a program that utilizes a quality system (QS) maturity model, including maturity criteria for each QS element, to self-assess the relative health, effectiveness and maturity of the QS at manufacturing locations and corporate QS functions. In this session, we will also discuss examples of specific quality systems and what good and bad might look like from an investigator’s perspective.

1:30 p.m. – 2:00 p.m.
Capability Maturity Model Integration
Kevin Cloonan, Director of Quality Continuous Improvement, Baxter Healthcare
 
2:00 p.m. – 2:30 p.m.
Quality Systems Inspection-Related Findings
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA 

2:30 p.m. – 3:00 p.m.
Questions and Answers/Discussion

Innovation

C1: Expedited Pathways: Developing a Quality Product under Accelerated Timelines
Moderator: Janice T. Brown, PhD, Acting Branch Chief, Division of Internal Policies and Programs, CDER, FDA

Session Description: Expedited programs for serious conditions typically have a shorter clinical development program. The accelerated pace of the clinical program requires shorter process and product development timelines to ensure availability of quality product at the time of approval. This session will explore product quality challenges and successful approaches for product development under abbreviated timelines and early interactions to facilitate the introduction of new technologies.

1:30 p.m. – 2:00 p.m.
Risk Benefit Considerations in Accelerated Product Quality Development
Earl Dye, PhD, Director, CMC Regulatory Policy, Genentech, Inc., A Member of the Roche Group 

2:00 p.m. – 2:30 p.m.
Early Quality Assessment Interactions for New Technologies
U.S. FDA CDER Representative Invited

2:30 p.m. – 3:00 p.m.
Questions and Answers/Discussion

3:00 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m.
Concurrent Sessions

Product Quality

A2: Quality Culture and Enabling Lifecycle Quality Improvement
Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

Session Description: This session will examine management’s role in creating a strong quality culture. Speakers will discuss the key attributes of an effective quality culture and characteristics of ineffective cultures. Hear examples that will illustrate both type of cultures and how deficient cultures can be addressed. The speakers will also discuss the influence of culture on process performance, how to institutionalize continual quality improvement thinking, implementation challenges, tips and how to measure your quality culture.

3:45 p.m. – 4:15 p.m.
The Impact of Quality Practices and Quality Behavior on Plant Performance: Redefining the Importance of Culture
Thomas Friedli, Associate Professor of Management, University of St. Gallen

4:15 p.m. – 4:45 p.m.
Aspiring to Measure Quality Culture: PDA Pilot Results
Cylia Chen-Ooi, External Affairs Senior Manager, International Quality, Amgen, Inc.

4:45 p.m. – 5:15 p.m.
Panel Discussion
Cylia Chen-Ooi, External Affairs Senior Manager, International Quality, Amgen, Inc.
Thomas J. Cosgrove, JD, Director, Office of Manufacturing Quality, CDER, FDA 
Thomas Friedli, Associate Professor of Management, University of St. Gallen

Lifecycle

B2: ICH Q12 Change Management and Risk Management
Moderator: John D. Ayres, MD, JD, Senior Medical Fellow, Product Safety Assessments, Global Patient Safety, Eli Lilly and Company

Session Description: ICH Q12 proposes the development of a harmonized pharmaceutical quality system that encompasses the product lifecycle and emphasizes integration of design space planning, quality risk management and manufacturing science. This session will offer you FDA and industry perspectives on change management across the product lifecycle and help you understand the opportunities and challenges in incorporating risk management principles into a change paradigm framework.

3:45 p.m. – 4:15 p.m.
Pharmaceutical Product Lifecycle Management: ICH Q12 and the Role of Risk Management
U.S. FDA CDER Representative Invited

4:15 p.m. – 4:45 p.m.
Industry Perspective on ICH Q12 Change Management and Risk Management
Andrew C. Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk Inc.

4:45 p.m. – 5:15 p.m.
Questions and Answers/Discussion

Innovation

C2: Advanced Therapies
Moderator: Carol L. Rehkopf, Chief, Review Management Business Operations Staff, CBER, FDA

Session Description: New technological advancements in science have led to emerging therapeutic approaches to treating disease. Cell and gene therapy products are one of many of these advanced therapies. This session will address some of the regulatory challenges that industry and the FDA have encountered as they move through the development lifecycle of these products.

3:45 p.m. – 4:15 p.m.
Industry Perspective on Advanced Therapies
Industry Representative Invited

4:15 p.m. – 4:45 p.m.
Regulatory Perspective on Advanced Therapies
Deborah A. Hursh, PhD, Senior Investigator, CBER, FDA 

4:45 p.m. – 5:15 p.m.
Questions and Answers/Discussion

5:30 p.m. – 6:45 p.m.
Concurrent Interest Group Sessions

IG1: Vaccines
Leader: Robert Darius, Owner, Radius Biotechnology Consulting, LLC

Description: The Vaccines Interest Group (VIG) focuses on issues that affect the biological, biotechnology, and vaccine industry. The Interest Group has previously discussed regulatory issues, new technologies, and emerging industry trends. Recent issues include vaccine availability and supplies, homeland security, and inspection trends. The group also issues a newsletter (VIG). All PDA members are welcome to attend VIG meetings, which are held in conjunction with PDA events.

IG2: Quality Systems
Leader: Jennifer Magnani, Senior Director, Quality Academy, Sanofi Pasteur

Description: The PDA Quality Systems Interest Group is a network of QA/QC professionals. Past topics have dealt with diverse subjects ranging from Systems Based Inspections, to QA /QC Organizations, to Risk Analysis. The Quality Systems Interest Group also sponsors a Quality Systems Forum on the PDA Web site for daily networking opportunities. Members participate in Task Forces on Compliance and Quality related topics.

IG3: Visual Inspection of Parenterals and Packaging Science
Visual Inspection of Parenterals IG Leader: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
Packaging Science IG Leader: Roger Asselta, Senior Advisor, Genesis Packaging Technologies

Description: The Visual Inspection of Parenterals and Packaging Science Interest Groups will be holding a joint session at the PDA/FDA Joint Regulatory Conference. There are many topics of mutual interest and this is an excellent opportunity to discuss them together.

Particulate contamination reduction in parenteral drug products is currently a key area of focus for many pharmaceutical companies as well as those who regulate the industry. We will have a brief presentation to provide an overview of current regulatory and compendial requirements and actions as well as pharmaceutical industry experience and expectations. One barrier for further particulate reduction is a lack of common test methods and baseline particulate data from container/closure component suppliers. A comparison of common test methods illustrates the gap between the compendial methods utilized by the pharmaceutical companies and the methods used by many container/closure component suppliers. 

We will use this joint session to discuss your packaging and inspection experience and concerns with specific focus on potential initial steps that container/closure component suppliers and pharmaceutical manufacturers might take to better understand and control particulate contamination.

IG4: Supply Chain Management
Leader: Amelia Mutere, MS, Head, Global Quality Inspection Management, Roche

Description: At this meeting of the Supply Chain Management Interest Group, we will discuss the importance of good supplier control for disposables and filters. We will also discuss PDAConnect, hot topics and best practice in materials management.

IG5: Quality Risk Management
Leaders: Amanda Bishop McFarland, MS, Consultant, ValSource, LLC., Emma Ramnarine, Head, Global Biologics Quality Control, Genentech/Roche and Magaly Aham, MS, RAC-US, Vice President of Compliance and US Operations, Pharma-Bio Serv

Description: The Quality Risk Management (QRM) Interest Group and its ConnectSM social media page are excellent avenues for you to raise questions, seek answers, share experiences, generate discussions and in general, interact with peers. The mission of our QRM Interest Group is to learn, promote and share best practices within our Interest Group community that can help us advance QRM practices in our respective organizations and in the industry as a whole. Your participation serves a critical function in not only building and advancing communications within this Interest Group, but can also help with our own QRM implementation journeys. So join us for another engaging exchange on practical QRM application topics to get your questions answered and leverage practices/learnings from other industry colleagues. 

IG6: Pharmacopeial
Leaders: Janeen Skutnik-Wilkinson, Lead Quality Intelligence and Compendial Affairs, BIOGEN and Karen S. Ginsbury, MSc, President and CEO, Pharmaceutical Consulting Israel Ltd.

Description: This meeting of the Pharmacopeial Interest Group will cover the challenges companies face in complying with global Pharmacopoeia's with a focus on two key areas:
1. The Chinese pharmacopeia 2015 and the pathway to 2020, including challenges faced by industry and how PDA is working to address concerns for the 2020 edition; and
2. Discussion and sharing amongst participants of best practices for compendial compliance.

6:45 p.m. – 8:30 p.m.
Networking Reception in Exhibit Area

Tuesday, September 12, 2017

7:00 a.m. – 5:30 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions

Breakfast 1: Practical Guidance on How to Conduct and Evaluate an Effective Smoke Study
Moderator: Mai X. Huynh, MS, Supervisory Team Leader, CVM, FDA

Session Description: Smoke studies are a key activity in the qualification, maintenance and monitoring of an aseptic facility. However, discussions of the specific methods and techniques to conduct such studies have been lacking. This session aims to provide in depth information about airflow visualization tests and key activity when conducting smoke studies to qualify and/or requalify your cleanroom.

7:15 a.m. – 7:40 a.m.
Airflow Pattern Testing and Documentation for Aseptic Processing
Donald E. Hill, PE, President, AccuTec Services, Inc.

7:40 a.m. – 8:15 a.m.
Panel Discussion
Maan S. Abduldayem, MBA, Consumer Safety Officer, CDER, FDA 
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA
Donald E. Hill, PE,
President, AccuTec Services, Inc.

Breakfast 2: Best Practices for CMC NDA Supplement Submissions
Moderator: David J. Cummings, MPH, Lead Interdisciplinary Scientist, OPQ, FDA

Session Description: This breakfast session will focus on the best practices for CMC NDA submissions to the Office of Lifecycle Drug products. The session will also discuss common approaches, challenges and lessons learned to navigate CMC-related NDA submissions.

7:15 a.m. – 7:45 a.m.
Regulatory Perspective on Best Practices for CMC NDA Supplement Submissions
U.S. FDA CDER Representative Invited

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 3: 3D Printing in the Advancement of Medicine
Moderator: Colleen F. Hoyt, Branch Director, Team Biologics Branch, ORA, FDA

Session Description: Additive manufacturing, also known as 3D printing, has created avenues of potential in the medical product industries through newly enabled design possibilities and personalized medicine capabilities. Forecasts project significant growth of 3D printing in the medical device space by 2025.  FDA’s Center for Devices and Radiological Health has cleared and approved several types of 3D-printed medical devices through its existing regulatory pathways and FDA’s Center for Drug Evaluation and Research has also approved a 3D-printed drug product. FDA, through internal and collaborative research, is working to facilitate the innovative development and assessment of innovative products in this space. 

This presentation will provide a snapshot of ongoing research efforts internally and in collaboration with FDA’s academic partners. Some topics will include phantoms for device testing, patient-matched devices instrumentation, cleanability assessment, material optimization and drug printing optimization.

7:15 a.m. – 7:45 a.m.
Regulatory Perspective on 3D Printing in the Advancement of Medicine
James Coburn, Senior Research Engineering Officer, CDRH, FDA

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 4: Digital Health
Moderator: Shane D. Killian, MS, Senior Director, Licensing and Acquisition Head, Johnson & Johnson

Session Description: As referenced at FDA.gov, many stakeholders are involved in digital-health activities, including patients, healthcare practitioners, researchers and companies new to FDA regulatory requirements such as mobile application developers. This session will discuss the exciting area of digital health and provide both industry and regulator perspectives on the challenges of bringing digital-health products to market.

7:15 a.m. – 7:45 a.m.
Regulatory Perspective on Digital Health
Linda J. Ricci, Associate Director, Office of Device Evaluation, CDRH, FDA

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

8:30 a.m.-10:0 a.m.
P3: Innovation in  Medical Products: What the Future Holds
Moderator: Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

Session Description: The continued expansion of the therapeutic landscape, targeted therapies, novel companion and complementary diagnostics, including the further development of multiplex genomic testing platforms, represent some of the most complex medical products for the treatment of disease. Gain first-hand knowledge of new scientific and regulatory advancements from leading industry and Agency oncology, orphan drug and combination product experts, who contribute to patients’ access to innovative therapies while ensuring public safety.

Panel Discussion
Debra Y. Lewis, OD, MBA,
Deputy Director, Office of Orphan Products Development, FDA
Patricia Y. Love, MD, MBA,
Deputy Director, Office of Combination Products, FDA
Amy E. McKee, MD,
Deputy Director, Oncology Center for Excellence, FDA
Kirsten Paulson, MS,
Senior Director, Global CMC-Medical Device Lead, Pfizer, Inc.


9:45 a.m. – 4:00 p.m.
Exhibit Area Open

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area

10:45 a.m. – 12:15 p.m.
Concurrent Sessions

Product Quality

A3: Quality Metrics
Moderator: Steven R. Mendivil, Senior Advisor, International Quality External Affairs, Amgen, Inc.

Session Description: This session will provide an industry case study on metric utilization to drive quality and prevent drug shortages. The session will also include a panel discussion with trade organization representatives on issues raised on the latest FDA revised draft. FDA will be present during the panel discussion and questions and answers portion of the session.

10:45 a.m. – 11:05 a.m.
Utilizing Metrics to Drive Quality and Prevent Drug Shortages
Valerie Whelan,
Vice President, Corporate Quality, Amgen, Inc.

11:05 a.m. – 11:45 a.m.
Panel Discussion
Barbara Allen, PhD,
Senior Director, Global Quality Systems, Eli Lilly S.A. Irish Branch
Deborah M. Autor, Esq., Senior Vice President, Strategic Global Quality and Regulatory Policy, Mylan Inc. and Member, Association for Accessible Medicines
U.S. FDA CDER Representatives Invited
Harry Jeffreys, Vice President, Regulatory Affairs and Compliance, Catalent Pharma Solutions
Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

Lifecycle

B3: Lifecycle Management of a Legacy Biotechnology Process
Moderator: Laurie P. Norwood, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA

Session Description: Management of a product lifecycle is an ongoing process and can be challenging for biotech products that were approved many years ago. Often times, there are obstacles that interfere with moving forward to align an older technology and manufacturing method to meet modern expectations. In this session, you will hear case studies that outline modernization attempts made by manufacturers. We will also discuss the science and regulatory path to leap from an old process to something new. FDA panelists will be available to address questions regarding this challenging regulatory pathway.

10:45 a.m. – 11:15 a.m.
Manufacturing Site Transfer for a 30 year Old Therapeutic Protein: Regulatory and Technical Challenges
Susan Batcha, Global Regulatory CMC, Director, Novartis Pharmaceuticals Corporation

11:15 a.m. – 11:45 a.m.
Technology Advancements in the Treatment of Hemophilia A: From Blood to Gene Therapy
Peter Turecek, PhD, Senior Director, Global Medical Affairs, Scientific and Technical Expert, Hematology, Shire

11:45 a.m. – 12:15 p.m.
Panel Discussion
U.S. FDA CDER Representative Invited
Susan Batcha, Global Regulatory CMC, Director, Novartis Pharmaceuticals Corporation
Alexey Khrenov, PhD, Senior Staff Fellow, CBER, FDA
Anthony F. Lorenzo, Team Lead, CBER, FDA
Peter Turecek, PhD, Senior Director, Global Medical Affairs, Scientific and Technical Expert, Hematology, Shire

Regulatory

C3: Compliance and Enforcement Trends
Moderator: Douglas A. Campbell, Senior Consultant, Interpro QRA

Session Description: It’s back by popular demand! This session will include short presentations from CDER and CBER Compliance managers that are designed to provide more than just the usual “Top 10” 483 observations and a summary of the latest warning letters. These presentations will be followed by a panel discussion with panelists from each of the Agency’s Centers and will be an opportunity for participants to gather specific insight.

10:45 a.m. – 11:15 a.m.
CDER Regulatory Perspective on Compliance and Enforcement Trends
Francis Godwin, MBA, Division Director, CDER, FDA 

11:15 a.m. – 11:45 a.m.
CBER Regulatory Perspective on Compliance and Enforcement Trends
Robert D. McElwain, Consumer Safety Officer, CBER, FDA

11:45 a.m. – 12:15 p.m.
Panel Discussion
Francis Godwin, MBA, Division Director, CDER, FDA 
U.S. FDA CVM Representative Invited
Robert D. McElwain, Consumer Safety Officer, CBER, FDA
Carmelo Rosa, Director Division, International Drug Quality, CDER, FDA 

12:15 p.m. – 1:30 p.m.
Lunch on your own (Exhibit Area Closed) - A listing of local restaurants is available at the PDA registration desk

1:30 p.m. – 3:00 p.m.
Concurrent Sessions

Product Quality

A4: Overseeing Your Supply Chain
Moderator: Myriam M. Sosa, MS, Executive Director, GMP Remediation and Support, Merck & Co./Merck Sharp & Dohme

Session Description: Managing risk in your supply chain requires meaningful quality agreements, effective audits, ongoing communications and prompt notifications regarding significant changes or problems. This session will discuss qualification of CMOs and vendors and what is needed to enable lifecycle quality assurance.

1:30 p.m. – 2:00 p.m.
CMOs: Quality Agreements and Audits
Paula Katz, JD,
Director, Manufacturing Quality Guidance and Policy Staff, CDER, FDA 

2:00 p.m. – 2:30 p.m.
Vendor and CMO Qualification: Lessons Learned
Zena G. Kaufman,
Vice President, Quality, Roivant Sciences, Inc.

2:30 p.m. – 3:00 p.m.
Questions and Answers/Discussion

Lifecycle

B4: Center International Affairs Leaders Discuss the Global Reach of FDA
Moderator: Colleen F. Hoyt, Branch Director, Team Biologics Branch, ORA, FDA

Session Description: Given the complexities of supply chains for pharmaceutical products and medical devices, FDA’s work includes important global elements that must be balanced with Agency priorities and mandates. How does FDA prioritize its global engagement? Meet the international affairs leaders from CBER, CDER, CVM and ORA, who will describe their Centers’ work on the global front, including regulatory harmonization, regulatory capacity building, information sharing, international standards setting and collaborative research.

1:30 p.m. – 2:00 p.m.
The New Face of Harmonization
Theresa M. Mullin, PhD, Director, Office of Strategic Programs, CDER, FDA

2:00 p.m. – 2:30 p.m.
Beyond Harmonization
Joan W. Blair, MA, Senior Advisor for International Affairs, CBER, FDA

2:30 p.m. – 3:00 p.m.
Panel Discussion
Joan W. Blair, MA, Senior Advisor for International Affairs, CBER, FDA
Niraj Mehta, PhD, Associate Director for Global Regulatory Policy, OC, FDA
Theresa M. Mullin, PhD,
Director, Office of Strategic Programs, CDER, FDA
U.S. FDA CVM Representative Invited

Regulatory

C4: Fishbowl
Moderator: Monica E. Caphart, MPH, Leveraging and Collaboration Program Manager, ORA, FDA (Invited)

Session Description: The fishbowl session is your chance to actively participate in the Conference! You will be presented with real life case studies or scenarios where you will need to consult with members of your team and try to come up with a solution to the problems presented. You can also pick if you want to participate by roleplaying either a member of industry or a member of the U.S. FDA.

Each group will have the opportunity to explain their solution and hear the solutions of others. There is no right or wrong answer, this is just a great way to interact and learn from your fellow Conference attendees.

Facilitators:
U.S. FDA CDER Representative Invited
Mai X. Huynh, MS, Supervisory Team Leader, CVM, FDA
U.S. FDA CDER Representative Invited

U.S. FDA CDER Representative Invited
U.S. FDA ORA Representative Invited

3:00 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m.
Concurrent Sessions

Product Quality

A5: FDA Program Alignment
Moderator: Douglas A. Campbell, Senior Consultant, Interpro QRA

Session Description: Program Alignment is a plan that will transition FDA to distinct commodity-based and vertically integrated regulatory programs. ORA and each Center has collaborated and developed action plans for specialization and coordination in an effort to better fulfill the FDA’s responsibilities to meet the emerging global challenges within the regulated industries. This session will present the action plans and provide information about how the changes in FDA’s structure, function and processes might have an effect on your next FDA inspection.

3:45 p.m. – 4:15 p.m.
Regulatory Perspective on FDA Program Alignment
U.S. FDA ORA Representative Invited

4:15 p.m. – 5:15 p.m.
Questions and Answers/Discussion

Lifecycle

B5: Advances in Manufacturing of Biological Products
Moderator: Maria "Reyes" Candau-Chacon, PhD, Biologist, CDER, FDA

Session Description: As new technologies emerge, the pharmaceutical industry is implementing more flexible and efficient manufacturing processes. Advancements in high-yielding expression systems and high-density cell culture processes, coupled with the use of single use bioreactors and vessels, result in higher productivities, flexibility and simplified equipment preparation.
Closed processes decrease microbial contamination and cross-contamination risks in multiproduct facilities. The development of high-titer membrane chromatography systems has the potential to eliminate bottlenecks in purification with the use of new high-throughput and continuous purification technologies. These process and technology advances will provide for the tools necessary to face the challenges of the current pharmaceutical needs.

3:45 p.m. – 4:15 p.m.
Transforming Operations with Next-Generation Biomanufacturing
Arleen Paulino, Vice President, Singapore Site Operations, Amgen Singapore Manufacturing Pte. Ltd. 

4:15 p.m.  – 4:45 p.m.
New Developments in the Manufacturing of Biological Products
U.S. FDA CDER Representative Invited

4:45 p.m. – 5:15 p.m.
Panel Discussion
U.S. FDA CDER Representative Invited
U.S. FDA CDER Representative Invited
Arleen Paulino, Vice President, Singapore Site Operations, Amgen Singapore Manufacturing Pte. Ltd. 

Regulatory

C5: Regulatory Considerations
Moderator: John D. Ayres, MD, JD, Senior Medical Fellow, Product Safety Assessments, Global Patient Safety, Eli Lilly and Company

Session Description: Generally, human factor (HF) studies are conducted to evaluate the user interface of a product. For a combination product that includes drug and device constituent parts, both the device design control requirements and drug development expectations apply to the entire combination product. HF studies are needed to ensure that use-related hazards associated with the product are eliminated or mitigated to reduce patient adverse events and medication errors. HF and the totality of available information (e.g., clinical, PK/PD, human factors, engineering, chemistry) are used in making safety and efficacy assessments for clinical trials bridging. This session will focus on HF considerations for combination products to promote consistency in their design and development. The data necessary in the bridging studies for the to-be-marketed combination product will also be considered. Additionally, usability issues facing industry and implications for combination product development will be highlighted.

3:45 p.m. – 4:15 p.m.
Quality Assurance
Shannon M. Hoste, MS, RAC, Senior Human Factors Engineer, CDRH, FDA

4:15 p.m. – 4:45 p.m.
Human Factors Role in the to-be-Marketed Combination Product Device Bridging Strategy
John Towns, PhD, Senior Research Fellow – Regulatory – Delivery Systems, Eli Lilly and Company 

4:45 p.m. – 5:15 p.m.
Questions and Answers/Discussion

5:30 p.m. – 6:45 p.m.
Concurrent Interest Group Sessions

IG7: Regulatory Affairs
Leaders: Ruhi Ahmed, PhD, RAC, Vice President, Regulatory Affairs, Inozyme Pharmaceutical Inc. and Ursula Busse, PhD, MBA, Quality Intelligence, External Relations, Novartis

Surveillance and Implementation of National Requirements in a Global Industry
Description: The regulatory environment is continuously evolving and companies are expected to stay compliant with new and updated regulations in all the markets where they have marketed products. How to capture, understand and implement all these new requirements in a timely manner becomes more and more important. This session will showcase an example of a process designed to ensure capture, influence, analysis and implementation of new regulatory requirements. The presentation will be followed by an interactive discussion where participants can share from their own experience. The complexity of the regulatory environment and the need for harmonization will also be addressed. 

IG8: Inspection Trends
Leaders: Christopher S. Carter, Senior Manager, Global Quality Systems, Mylan Pharmaceuticals and Dipti Gulati, MBA, PhD, President, PJI Biotech

Description: A review of the recent inspectional observation by topics will be discussed in an interactive manner. Past topics have included data integrity, aseptic practices and facility conditions.

IG9: Lyophilization and Sterile Processing/Parenteral Drug Manufacturing
Lyophilization IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc.
Sterile Processing/Parenteral Drug Manufacturing IG Leader: Rebecca Brewer, Strategic Practice Lead, Quality Executive Partners, Inc.

Description: Recent inquiries and inspection observations have raised questions about proper approaches to the design of Aseptic Process Simulations (APS). These include such topics as the length of time filled vials need to sit in the lyophilizer, as well as the need of different filling line change parts need to be incorporated within a matrix. The session will open with highlights on recent considerations in the design of an APS. The IG session will then be an open forum for discussions on these and other current topics in sterile products and lyophilized preparations. 

This session will encompass both liquid and lyophilized products, with a focus on considerations for regulatory inspections. In this open forum format, topics are identified by participants for discussions by the group. This provides a unique opportunity to learn from a variety of experiences and perspectives, and provides an excellent benchmark for current industry practices.

IG10: Facilities and Engineering
Leader: Shelley Preslar, MBA, PMP, General Manager, Azzur Group

Description: The Facilities and Engineering Interest Group provides a forum for the discussion of topics and interests related to the design, construction, operation and maintenance of the production and research facilities used for GMP and GLP purposes. Discussions are held in conjunction with two of the PDA meetings: the Annual Meeting and the PDA/FDA Joint Conference, as well as a discussion forum on the PDA website.

The format of the Facilities and Engineering Interest Group meetings are an open forum for discussion, where attendees select the topic for discussion and the leader moderates the discussion of peers seeking to reach a better understanding of regulatory expectations and opportunities to share and learn best practices. Where appropriate, the Facilities and Engineering Interest Group will compile these understandings and best practices into technical reports with the contributions and review of interested members.

IG11: GMP Links to Pharmacovigilance
Leaders: Agnieszka Majcher-Dann, MD, Head of Safety Sciences and Policy, Consumer Segment, Johnson & Johnson and John D. Ayres, MD, JD, Senior Medical Fellow, Product Safety Assessments, Global Patient Safety, Eli Lilly and Company

Description: The GMP Links to Pharmacovigilance Interest Group will facilitate the incorporation of medical expertise and oversight in the form of a clinical assessment of the potential safety issues with product performance and Quality System elements.  Quality attributes of a product, including product specifications, are linked to patient experiences and add value to fundamental quality activities.

The focused elements for this Interest Group are as follows:

  • Risk control linked to medical patient risk
  • To link Quality System elements to Pharmacovigilances and Approved Risk Evaluation and Mitigation Strategies (REMS)
  • To address link recalls, complaints and adverse effects
  • The establishment of and deviation from Critical Quality Attributes (CQAs) and the link to the Quality *Target Product Profile (QTPP)
  • The link to Regulatory filing issues (e.g., label claims).

The mission is achieved by:

  • An improved understanding of the clinical (patient experiences) and GMP Quality Systems (product specifications)
  • Discussing case studies of positive and negative experiences in this venue
  • Contributing to global regulations and guidance as appropriate
  • Sponsoring plenary sessions, break-out sessions, and possibly a conference to bring together experts in this field.

IG12: Technology Transfer
Leaders: Mirko Gabriele, Senior Manager, Global DPS Technology Transfer, Patheon and Melissa Seymour, MBA, Vice President, Global Quality Control, Biogen

Description: This interest group is focused on the benchmarking of our experience in Technology Transfer projects. In this session, we will explore ongoing activities within the Tech Transfer Interest Group. This includes generation of a matrix which can serve as a template to standardize approaches within industry, discussion of overall governance and strategy with respect to Tech Transfer as well as a library of guidance documents. The meeting is an open discussion format with a moderator and will provide an open forum for discussion around any and all Tech Transfer related activities including manufacturing process transfer, analytical transfer, and equipment user requirements definition. The group discussion at PDA/FDA will focus on “Benchmarking Tech Transfer Activities”. Including:

  • What are the expectations with respect to documentation?
  • How many regulations apply to Tech Transfer? In which markets?
  • What kind of Governance and oversight is needed for Tech Transfers?
  • How can I assess risk and use this to define my Tech Transfer Deliverables?
  • Potential development of an interactive tool/standard for how to measure the variance to the benchmark based on the change in cumulative risk
    • Allows association of deliverable sets to changes in cumulative risk profile (i.e., total number of documents)
    • Provide deliverable duration estimates associated with document rigor as determined by cumulative risk (i.e., complexity of documents)
If you have other related issues or questions you would like to raise you can add new and different ideas to this session.

6:30 p.m. – 9:00 p.m.
Networking Reception

Wednesday, September 13, 2017

7:15 a.m. – 12:00 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions

Breakfast 5: Process Validation of Sterile Products
Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

Session Description: This session will explore validation of aseptic processes and the issues that are encountered, including designing aseptic processes to minimize contamination risk, handling media fill failures, minimizing and optimizing interventions, assessing hazards posed by ISO 5 contamination incidents and evaluating control system failures.

7:15 a.m. – 7:45 a.m.
Aseptic Process Design and Media Fill Validation
Tamara L. Ely, MS, Senior Policy Advisor,  CDER, FDA 

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 6: Quality Assurance 101
Moderator: Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

Session Description: If you are an avid follower of warning letters, then you know that many of the infractions companies are being cited on are very basic concepts. Not following SOPs, not following good documentation practices, data integrity citations and incomplete investigations are among the top observations. Come and hear an expert panel talk about the importance of getting back to basics, so that you can avoid these all-too-common pitfalls.

7:15 a.m. – 8:15 a.m.
Panel Discussion
Jeff Broadfoot, Senior Director, Quality, Emergent BioSolutions and Chair, PDA Regulatory Affairs and Quality Advisory Board
Jackie Veivia-Panter, MBA, Director, Quality Systems, Celgene and Vice-Chair, PDA Regulatory Affairs and Quality Advisory Board
Steven Lynn, MS, Global Head Group (Corporate) Compliance and Audit, Novartis and Member, PDA Regulatory Affairs and Quality Advisory Board (Invited)

Breakfast 7: Microbiology Laboratory Controls
Moderator: Jacqueline Kunzler, MBA, PhD, Senior Vice President, Global Quality, Baxter Healthcare Corporation

Session Description: Often taken for granted, the microbiology laboratory could have a significant impact on assuring sterility of parenteral drugs. This session will discuss the many faceted issues that can affect the validity of management information and product release decisions (e.g., sample handling controls, data integrity issues, identification problems, investigations and the impact of facility and equipment functionality).

7:15 a.m. – 7:45 a.m.
Industry Perspective on Microbiology Laboratory Controls
Marsha Steed (Hardiman), Senior Consultant, Valsource, LLC

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 8: Role of Standards in the Pharmaceutical Industry
Moderator: Maria Guazzaroni Jacobs, PhD, Director, Quality and Regulatory Policy (QRP), Pfizer, Inc.

Session Description: This session will discuss the use of standards, such as ANSI, ASTM, USP and others in the pharmaceutical industry. CDER’s Office of Pharmaceutical Quality leads interactions with the USP as well as with voluntary standards development organizations. This interagency collaboration supports guidance development and standards related policy-setting activities relevant to pharmaceutical quality. The session will start with a presentation by an OPQ/CDER representative followed by questions and answers.

7:15 a.m. – 7:45 a.m.
FDA Interaction with Standard-Setting Organizations and Use of Standards in the Pharmaceutical Industry

U.S. FDA CDER Representative Invited

7:45 a.m. – 8:15 a.m.
Panel Discussion
Scott A. Colburn, CAPT, USPHS, Director, Standards Program, CDRH, FDA
Mai X. Huynh, MS, Supervisory Team Leader, CVM, FDA
U.S. FDA CDER Representative Invited

Breakfast 9: Bridging Cultures in Pharmaceutical Development and Manufacturing
Moderator: Renée Kyro, MBA, Director, QA Compliance Program Management, Quality Assurance, AbbVie

Session Description: Rapidly developing and registering innovative medical products is greatly influenced by the ability of cross-functional teams to effectively and efficiently work together. Cultures within R&D and Operations functions have historically been very different. In this session, you will hear how industry is closing the cultural gaps to ensure successful scale up, product realization and knowledge transfer throughout the product transfer lifecycle.

7:15 a.m. – 7:45 a.m.
Industry Perspective on Bridging Cultures in Pharmaceutical Development and Manufacturing
Industry Representative Invited

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

8:30 a.m. – 10:00 a.m.
P4: Center Updates
Moderator: Shane D. Killian, MS, Senior Director, Licensing and Acquisition Head, Johnson & Johnson

Session Description: Hear directly from senior management officials representing the various Agency Center Directors and learn about the latest regulatory expedited pathways, policy developments, priority initiatives and other activities planned for 2018 and beyond. A panel discussion will follow along with time for questions from the audience.

Panel Discussion
Christopher C. Joneckis, PhD, Senior Advisor, CBER, FDA
Robin W. Newman, MSN, EdD, CPNP,
Director, Office of Compliance, CDRH, FDA
Steven M. Solomon, DVM,
Director, CVM, FDA
Douglas C. Throckmorton, MD, Deputy Center Director for Regulatory Programs, CDER, FDA 

10:30 a.m. – 12:00 p.m.
P5: Compliance Update
Moderators: Steven R. Mendivil, Senior Advisor, International Quality External Affairs, Amgen, Inc.

Session Description: Attend this “save-the-best-for-last” session featuring the Compliance Directors from the FDA Centers and Office of Regulatory Affairs. In this session, learn more about FDA’s new initiatives, programs and significant manufacturing compliance deficiencies that could affect medical products. Don’t miss this opportunity to ask those questions you have always wanted to ask a panel of experts in an open forum setting.

Panel Discussion
Donald D. Ashley, JD, Director, Office of Compliance, CDER, FDA
Sean M. Boyd,
Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA
Martine L. Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, CVM, FDA 
Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
Douglas W. Stearn, JD, Director, Office of Enforcement and Import Operations, ORA, FDA



Conference and Workshop Registration | September 11-14, 2017

Member

Before June 30, 2017
$3,740

June 30 - August 1, 2017
$4,190

After August 1, 2017
$4,640

Non-member

Before June 30, 2017
$4,219

June 30 - August 1, 2017
$4,669

After August 1, 2017
$5,119


Conference Registration | September 11-13, 2017

Member

Before June 30, 2017
$2,395

June 30 - August 1, 2017
$2,795

After August 1, 2017
$2,995

Non-member

Before June 30, 2017
$2,674

June 30 - August 1, 2017
$3,074

After August 1, 2017
$3,274


Government/Health Authority†

Member*

Before June 30, 2017
$700

June 30 - August 1, 2017
$700

After August 1, 2017
$700

Non-member*

Before June 30, 2017
$700

June 30 - August 1, 2017
$700

After August 1, 2017
$700


Academic

Member

Before June 30, 2017
$700

June 30 - August 1, 2017
$700

After August 1, 2017
$700

Non-member*

Before June 30, 2017
$800

June 30 - August 1, 2017
$800

After August 1, 2017
$800


Student

Member

Before June 30, 2017
$280

June 30 - August 1, 2017
$280

After August 1, 2017
$280

Non-member*

Before June 30, 2017
$310

June 30 - August 1, 2017
$310

After August 1, 2017
$310

All prices in US dollars.

† If you are a Government/Health Authority Member Type, you must use the Government/Health Authority Registration Form.
* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this workshop.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference and receive the 5th registration free. Other discounts cannot be applied. Complimentary Conference registration does not qualify for discount offered for Workshop.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by July 13, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). If your written request in received on or before July 13, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials onsite. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA Conferences.

Renaissance Washington, DC Downtown Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000

Rate: Single: $315.00, plus applicable taxes (14.5%).

Cut Off Date: Friday, August 11, 2017 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.

Hotel Accommodations

To make reservations at the Renaissance Washington, DC Downtown Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2017 PDA/FDA Joint Regulatory Conference, and the 2017 PAC iAM Workshop to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron and an ironing board.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

Ground Transportation
Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

Metro
Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train
Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

Driving
Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking
$35 / Daily Self-Parking
$45 / Daily Valet Parking

Network, Collect Intelligence and Forge Key Relationships

The PDA/FDA Joint Regulatory Conference is one of PDA's Signature Events, and one of our most popular meetings, typically attracting more than 700 Conference attendees. With multiple networking breaks and reception, exhibitors have ample time to connect with their desired audience of industry leaders, strengthen business relationships and create new sales leads. As an exhibitor, you will gain access to hundreds of industry professionals with direct responsibility in biopharmaceutical manufacturing, quality, compliance, operations, supply chain, engineering, project management, regulatory affairs and science.


Increase Brand Recognition

High-profile support packages are available for lanyards, notepads, wireless internet service, audience response systems, tote bags, hotel keycards, mobile device charging stations, refreshment breaks, lunch and networking reception. We'll create a customized support package to fit your needs and budget.

For more information about exhibit and support opportunities, please contact either:

David Hall
at +1 (301) 656-5900 ext. 160; cell +1 (240) 688-4405; hall@pda.org

Alison Caballero at +1 (301) 656-5900 ext. 135; caballero@pda.org.

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