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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 Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
Exhibition: September 11-12
Post-Workshop: September 13-14
Courses: September 14-15
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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.

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. An FDA representative 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 the Defense Advanced Research Projects Agency (DARPA) talk about how their organization is advancing medical products through technological innovation in in biology and engineering. Collectively, participants 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. Attendees 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.
Regulatory Keynote Address 

9:00 a.m. – 9:30 a.m.
Federal Stakeholder Keynote Address

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, Science & Regulatory Quality, Office of Manufacturing QualityFDA

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.

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, QA 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.

Lifecycle

B1: Quality Systems
Moderator: Jackie Kunzler, MBA, PhD, Global Head of Quality, Baxter International Inc.

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. When we think about QSs, does one size fit all? In this session, we will also discuss how to optimize QS.

Innovation

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

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: Overseeing Your Supply Chain
Moderator: Myriam Sosa, MSExecutive Director, Quality Assurance Compliance, 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. A regulator will also join the panel to answer questions on the new FDA quality agreement guidance.

Lifecycle

B2: ICH Q12 Change Management & 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.

Innovation

C2: Advanced Therapies
Moderator: Carol L. Rehkopf, Consumer Safety Officer, 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.

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

6:30 p.m. – 8:00 p.m.
Networking Reception in Exhibit Area

Tuesday, September 12, 2017

7:15 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

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.


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 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.

Lifecycle

B3: Lifecycle Management of a Legacy Biotechnology Process
Moderator: Laurie P. Norwood, Deputy Director, Office of Compliance & 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. An FDA panelist will be available to address questions regarding this challenging regulatory pathway.

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 an extended Q&A session with panelists from each of the Agency’s Centers and ORA and will be an opportunity for participants to gather specific insight. 

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

Session Description: This session will provide updates on quality metrics, including an update from FDA and industry regarding the reissued metrics guidance and comments received. A number of issues have been raised that may be obstacles for firms participating in the voluntary phase of the metrics pilot scheduled to begin in early 2018. The session will discuss those issues and possible solutions to facilitate more participation in the voluntary phase.

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, CDRH 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.

Regulatory

C4: Fishbowl
Moderators: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.and Monica E. Caphart, MPH, Leveraging & 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.

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.

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. 

Lifecycle

B5: Advances in Manufacturing of Biological Products
Moderator: 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. 

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.

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

7:00 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

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

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.

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.

* 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: Thursday, 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.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3540

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