8:30 a.m. – 9:00 a.m.
Regulatory Perspective: Quality Systems, Quality by Design and Drug Shortages - Where are we?
Janet Woodcock, MD, Director, CDER, FDA

9:00 a.m. – 9:30 a.m.
Industry Perspective: Quality Systems, Quality by Design and Drug Shortages
Daniel Kraft, MD, Executive Director, FutureMed

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

10:45 a.m. - 11:10 a.m.
How to Implement a Quality Culture Across Multiple Sites
Marty Murawski, Vice President, Quality Management and Continuous Improvement, Hospira, Inc.

11:10 a.m. – 11:35 a.m.
How The Quality Culture Impacts the Effectiveness of a Quality System
Mary Oates, PhD, Vice President, Global Quality Operations and Environmental, Health and Safety, Pfizer, Inc.

11:35 a.m. – 12:00 p.m.
Common Findings to Defective Quality Systems
David Jaworski, Director, Lachman Consultant Services, Inc.

12:00 p.m. – 12:15 p.m.
Questions and Answers/Discussion

Moderator: Shane Killian, Director, Johnson & Johnson

Session Description: The discussion on the life cycle approach including concepts of QbD, Control Strategy and Continued Manufacturing can only be implemented if the API and drug product are manufactured. The lectures in this session will focus on preventing cross-contamination in facilities. The regulatory expectation on the multi-product facilities will be described. A practical example will demonstrate a decision making process on dedication, implement single-use technology or appropriate cleaning validation.

1:15 p.m. – 1:45 p.m.
FDA's Expectations for a Submission
CBER/FDA Speaker (invited)

1:45 p.m. – 2:15 p.m.
Decision Model on Running the Facility Scheme: Dedication, Single-use Technology or Appropriate Cleaning Validation
Morten Munk, Vice President, Business Development, CMC Biologics A/S

1:45 p.m. – 2:15 p.m.
Small Molecules
Sarah Pope, Chemistry Lead, CDER, FDA (invited)

2:15 p.m. – 2:45 p.m.
Questions and Answers/Panel Discussion

Moderator:  Maria Guazzaroni Jacobs, PhD, Director – Quality and Regulatory Policy, Quality Operations, Pfizer, Inc.

Session Description:
Most regulatory agencies around the world accept ICH Q7 as the GMPs to be applied to the manufacture of APIs. But what are the appropriate GMPs to apply to excipients and components? This session will discuss the expectations and regulations in Europe, US, and WHO, and present the view of regulators and industry. The use of risk assessment to the application of appropriate GMPs for these compounds will also be addressed. The session will also present an update on the Q&A being developed by the ICH Implementation Working Group on Q7.

Session Description:
On July 9, 2012 President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. This broad legislative package includes a number of initiatives aimed at improving the managed review process, enhancing continuity of drug supply, and bringing greater transparency to agency decision-making processes. In response to this legislation, a structured benefit-risk assessment (SBRA) is being implemented to enhance public transparency to FDA decision-making around patient benefit-risk. FDA and the industry have common interests in this initiative and are working in parallel to achieve the shared goals.

Participants will:

• Understand how use of risk management models is expanding outside the compliance arena to the broader clinical regulatory decision-making process
  
• Gain insights into how the risk assessment generated through this process will aid sponsors in meeting their reporting requirements under ICH E2C (PBRER – Periodic Benefit Risk Evaluation Report) and PSUR – Periodic Safety Update Report) in the future
  
• Be introduced to the BRAT (Benefit Risk Assessment Tool) framework developed by an industry working group.

Session Description:
A key phase in the Product Lifecycle is the technology transfer from development to commercial manufacturing. Integrating the concepts of ICH Q8 into product development along with the risk-based approach concepts of ICH Q9 will assist a company’s realization of a successful technology transfer. Using these integrated concepts with also provide a natural lifecycle progression into the concepts of ICH Q10 and continual improvement within the company’s Quality System. This session will explore industry experience with these concepts and submission expectations of the regulators central to this transition phase of the Product Lifecycle.

3:15 p.m. - 3:45 p.m.
GMP for API's
Alicia Mozzachio, Regulatory Director, CDER, FDA (invited)

3:15 p.m. - 3:45 p.m.
The Impact of FDASIA through-out the Industry
Doug Stearn, Deputy Director, Policy and Analysis, CDER, FDA (invited)

3:15 p.m. - 3:45 p.m.
Industry Perspective
Pfizer Speaker (invited)

3:45 p.m. – 4:15 p.m.
Embracing Excipient GMPs from a Global Perspective
Janeen Skutnik-Wilkinson, Senior Partner, NSF-DBA (invited)

3:45 p.m. – 4:15 p.m.
Regulatory Perspective
CDER/FDA Speaker (invited)

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

4:15 p.m. – 4:45 p.m.
Panel Discussion
Nisha Jain, Supervisory Medical Officer, CBER, FDA

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

IG1: Supply Chain Management

Interest Group Description: The following topics will be discussed in a panel setting with participation from industry leading companies. There will be presentations on the following topics:

• FDAASIA implementation,
• EU Falsified Medicines/QP Declaration and Excipients
• Regulatory updates

Interest Group Description: The Interest group will continue to explore current issues and new general chapters in the pharmacopoeias as well as discussing opportunities for international harmonization of monographs. The metal impurities issue continues to generate debate and with implementation date coming closer this will be one of the topics that will be presented. Further updates depending on activity closer to the conference date.

IG3: Inspection Trends

Interest Group Description: The Interest Group will review recent FDA inspectional observations specific to parenteral manufacturing such as media fills, particulates in parenteral arising from glass defects and Field Alert reporting will be discussed. Recent trends of recalls will also be reviewed.

Thomas Arista, Investigator, ORA, FDA (invited)

IG4: Filtration

Leader: Russell E. Madsen, President, The Williamsburg Group, LLC

Interest Group Description: The IG meeting will consist of an audience-directed panel discussion, wherein the attendees are polled for topics of interest, the topics are prioritized, and then discussed with input from an “expert panel” as necessary and appropriate. There will be no formal presentations. The panel will consist of several representatives from different filter companies and possibly the FDA.

CDER/FDA Speaker (Invited)

IG5: Process Validation 

Leaders: Scott Bozzone, PhD, Senior Manager, Validation, Quality Systems Technical Services (QSTS-V), Pfizer, Inc. & Harold Baseman, CEO, ValSource, LLC

Interest Group Description: We would like to continue having the Process Validation IG meeting at the PDA FDA Regulatory conference in Sept 2013. There remains a strong interest in the subject, since we have met at the last 5 conferences (Annual and PDA-FDA Reg. Conferences) and the PV IG meeting has been very well received in each of these. We have published PDA Tech Report 60 in February of this year. Furthermore, there are also key regulatory activities on-going in process validation such as:

• US FDA Process Validation Guidance (2011) many still have lots of questions and concerns on it.
• EMA is updating its Process validation Guidance and issued a draft in March 2012. We may see it finalized or a EMA response to comments by Sept 2013.
• EMA is revising Annex 15 on Validation and Qualification and has issued Concept paper on it.
• Other areas of world such as Asean and PIC/S PV Guides are actively pursuing regulatory impact of the above.

IG6: Visual Inspection

Leaders: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

Interest Group Description: The session plans to have one speaker to talk about a Life-Cycle Approach to Visual Inspection. This focuses on using Visual Inspection data to drive continuous process improvement (of both the inspection and manufacturing processes). We would also have our usual regulatory update including current activity at USP to establish a standard for visual inspection of particulates. We will have open discussion of hot topics of interest to those in attendance.

Interest Group Description: The PDA Quality System Interest Group is a network of quality professionals. An organization's Pharmaceutical Quality System (PQS) is the foundation for delivering quality products to patients. Our sessions are open to any industry professional interested in discussing and/or listening to PQS and ICH Q10 related topics. During the 2013 PDA/FDA meeting we will talk about Quality Metrics - what are the important ones that will show you have a good PQS, that your product health exceeds expectations and ones to use to assist in avoidance of drug shortages. FDA and industry experts will share their experiences and we will then kick off our usually lively and informative dialog.

Richard Friedman, Associate Director, OMPQ, CDER, FDA (invited)
Michelle Noonan-Smith, Quality System Specialist, CDRH, FDA (invited)

Moderator: Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.

Moderator: John Finkbohner, PhD, Senior Director, Regulatory Affairs, MedImmune, Inc.

Session Description:
Metrics are an important element in driving continuous quality improvement in today’s manufacturing environment. This breakfast session will educate the audience on the fundamentals of chosing meaningful quality metrics and how to interpret and make the necessary operational changes to improve product quality based on the data collection.

Session Description:
While much focus has been on the manufacturing process and product supply in recent years, the laboratory is also a critical part of a pharmaceutical operation. This session will discuss the importance of maintaining a reliable laboratory, and will include some FDA inspection findings in microbiology and chemistry laboratories.

Session Description:
Recent advances in information technology now afford manufacturing managers access to timely production data. Distant process monitoring can now give distant management team’s access to production information which can impact the resource cost associated with in-process monitoring. While the concept of distant monitoring is not a new concept to the manufacturing industry such as producers of medical gases, there are a number of challenges and opportunities when applied to various medical products manufacturing sectors. These topics for consideration include:

• Production of carcinogenic drugs,
• Selection of process parameters for monitoring,
• In-process detection of bioburden for aseptic processes,
• Automated analytical methods,
• Information security,
• Adequacy of regulations, and
• Generation of manufacturing and validation records.

Session Description:
Collaboration between the USP and FDA is extremely important in order to enhance and protect the quality of pharmaceutical products now and in the future. This session will focus on these collaborative efforts for current initiatives both at USP and FDA (e.g., monograph and general chapter modernization, elemental impurities). The session will address the opportunities that these collaborations present for securing the quality of the American drug supply.

7:15 a.m. – 7:35 a.m.
Regulatory Microbiology for Sterile Compounded Drugs: Samples to Suspects
Dennis Guilfoyle, PhD, Pharmaceutical Microbiologist, ORA, FDA

7:35 a.m. – 7:55 a.m.
Chemistry Lab Controls / Audit Findings
Michele Obert, Investigator, ORA, FDA (invited)

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

7:55 a.m. – 8:15 a.m.
Questions and Answers/Discussion

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

8:30 a.m. – 10:00 a.m.
P3- Understanding Good Manufacturing Practices
Moderator:  Richard Friedman, Associate Director, OMPQ, CDER, FDA

Session Description: 
This session will discuss how safety and efficacy is assured by routine adherence to the quality assurance and manufacturing control practices embodied in the GMPs. Presenters from FDA and industry will discuss how GMPs have evolved, and why responsive systems and good governance are so important to assure reliable pharmaceutical operations and safe products. Presenters will also discuss quality assurance lapses that led to major defects and manufacturing problems. The session will mix universal quality assurance principles with practical findings, and emphasize the essential role of robust quality systems in assuring the core business goals of reliable drug quality and availability.

8:30 a.m. - 8:55 a.m.
Evolution of GMP Provisions in the Act: Important Lessons Learned from History
Cathy Burgess, Partner, Alston and Bird

8:55 a.m. - 9:20 a.m.
Evaluating GMP Significance and Assuring Quality
Mary Anne Malarkey, Director, Office of Compliance, CDER, FDA (invited)

9:20 a.m. – 9:45 a.m.
Quality Matters: How the Preventive Systems of GMPs Meet Core Business Objectives
Juan Andres, Head, Group Quality, Novartis (invited)

9:45 a.m. – 10:15 a.m.
Panel Discussion:

• Juan Andres, Head, Group Quality, Novartis (invited)
• John D. Ayres, MD, Senior Director, Product Safety Assessments, Global Patient Safety, Eli Lilly & Company
• Cathy Burgess, Partner, Alston and Bird
• Mary Anne Malarkey, Director, Office of Compliance, CDER, FDA (invited)

Moderator: Steven Mendivil, Executive Director, International Quality External Affairs, Amgen, Inc.

Session Description:
EU has recently published final Good Distribution Guidance that contains new requirements for distribution within the Supply Chain. This session will highlight important new requirements with EU GDPs and look at other global distribution requirements and the mechanisms firms are putting into place to meet these new challenges.

Session Description:
Outsourcing various functions is an increasing trend in today’s industry. In some scenarios, everything from clinical trials to quality oversight of the manufacturing process is delegated to a service provider. This session will explore some of the novel approaches being taken by outsourcing companies and their contractual partners on how they communicate and improve quality when multiple parties, opinions and approaches are involved.

Session Description:
The management of the lifecycle of a product towards the commercial phase is multifaceted and requires appropriate attention. The establishment of the quality systems and robust technology transfer are essential parts to of activities towards commercialization. In addition, economical and risk based decisions need to be made to be prepared for a successful launch meeting the demands, but also to minimize financial burdens, if the product does not achieve its promised efficacies or safety. The speakers will address the different activities within the lifecycle management towards commercialization and thorough preparations necessary.

10:45 a.m. – 11:15 a.m.
Global Distribution Complexity
David Ulrich, Director QA, Distribution Global Pharmaceutical Operations, AbbVie, Inc. (invited)

10:45 a.m. – 11:15 a.m.
FDA Expectations for Outsourcing Activities
Laurie Norwood, Deputy Director, DMPQ, CBER, FDA

10:45 a.m. – 11:15 a.m.
Industry Perspective: Building up of a Quality System and Tech Transfer
Industry Speaker (invited)

11:15 a.m. – 11:45 a.m.
EU GDPs
Tony Orme, Senior GDP Inspector, MHRA (invited)

11:15 a.m. – 11:45 a.m.
Outsourcing Innovations from a CMO’s Perspective
EJ Brandreth, VP, Quality and Regulatory Affairs, Althea Technologies

11:15 a.m. – 11:45 a.m.
Regulatory Perspective: Building up of a Quality System and Tech Transfer
FDA Speaker (invited)

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

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

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

Moderator: Richard Friedman, Associate Director, OMPQ, CDER, FDA

Session Description:
This session will cover the latest news and trends in the areas of international regulatory collaboration and compliance. Major inspection findings, compliance actions, and joint regulatory efforts to converge inspection practices will be addressed by the presenters.

Session Description:
Dosage forms for drugs, biologics, and combination products are multi-varied and continuously evolving. This session will educate attendees on the current status of Companion Diagnostics and Combination Products.

Session Description:
Shortages of critically important medications adversely affect patient populations. What is your company doing to mitigate and prevent these shortages from occurring and ensure a dependable supply of high quality drug products to patients? Hear from industry leaders as they present their strategies for mitigating risk to prevent supply interruptions and the consequences of not making a product.

1:15 p.m. – 1:45 p.m.
Inspections
Carmelo Rosa, Director, Division of International Quality, OMPT, CDER, FDA (invited)

1:15 p.m. – 1:40 p.m.
Combination Products Regulation and Guidance Update
Patricia Love, Deputy Director Office of Combination Products, OC, FDA (invited)

1:15 p.m. – 1:45 p.m.
Economics in Drug Shortages
Marta Wosinska, Director, Economics Staff, CDER, FDA

1:45 p.m. – 2:15 p.m.
Collaboration
Raphael Brykman, Acting Team Leader, Office of Strategy, Partnerships and Analytics, OC, FDA (invited)

1:40 p.m. – 2:05 p.m.
CDRH Compliance Perspective on Combination Product Manufacturing and Controls
Isabel Tejero, Consumer Safety Officer, CDRH, FDA (invited)

1:45 p.m. – 2:15 p.m.
Strategies for Mitigating Risk to Prevent Supply Interruptions
Pfizer Speaker (invited)

2:05 p.m. – 2:30 p.m.
Companion Diagnostics
Elizabeth Mansfield, Director, Personalized Medicine Staff, Office of In-vitro Diagnostics, CDRH, FDA (invited)

2:30 p.m. – 2:45 p.m.
Questions and Answers/Discussion

2:15 p.m. – 2:45 p.m.
Questions and Answers/Discussion

Moderator: Douglas Campbell, Senior Consultant, Interpro QRA

Session Description:
Compliance is a common goal within the pharmaceutical industry. In the reality of the global regulatory environment, the FDA is actively conducting inspections and enforcement actions. Most will agree that there is a stigma attached to documented non-compliance, and this leads to anxiety, lack of understanding, and misconceptions about the process. This session will provide insight related to the expectations and responsibilities of all parties, while striving to initiate discussion related to transparency and communication with the FDA.

Session Description:
The U.S. FDA has developed a question-based review (QbR) for quality evaluation of human Abbreviated New Drug Application (ANDA) and veterinary drug applications (INAD, NADA, ANADA). This new QbR system incorporates quality by design and implements risk-based assessment. It recommends that CMC applications include the Quality Overall Summary (QOS) that addresses all the QbR questions. The main benefits of this QbR system are to 1) assure product quality through design and performance-based specifications, 2) facilitate continuous improvement and reduce CMC supplements through risk assessment, 3) enhance the quality of reviews through standardized review questions, and 4) reduce CMC review time when applicants submit a QOS that addresses the QbR questions.

Session Description:
It’s often seen that commerical manufacturing processes are ‘locked in’ after application approval and initial process qualification. There is often a minimal incentive to change and improve the manufacturing process to minimize variablity and improve performance due to perceived regulatory hurdles. This session reiterates the essentiality of continual improvement of the manufacturing process, its regulatory foundation, and its positive impact to the industry and patient. It will also highlight the need to utilize cross functional quality signals to identify process failure, optimize process capability, and improve product quality for the patient.

3:15 p.m. – 3:45 p.m.
Post-Inspection Expectations and Procedures: For International Drug Inspections
Carmelo Rosa, Director, Division of International Quality, OMPT, CDER, FDA (invited)

3:15 p.m. – 3:40 p.m.
Question Based Review
Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Science, CDER, FDA

3:15 p.m. – 3:45 p.m.
Regulatory Perspective on Post- Approval Manufacturing Optimization and Continuous Process Verification
Grace McNally, Senior Policy Advisor, CDER, FDA (invited)

3:45 p.m. – 4:15 p.m.
Post-Inspection Expectations and Procedures: For Domestic Drug Inspections
Nancy Rolli, Director, Compliance Branch, ORA, FDA (invited)

3:40 p.m. – 3:55 p.m.
Question Based Review- Sterile Products
Kristen Anderson, PhD, Senior Microbiologist, Division of Manufacturing Technologies, CVM, FDA (invited)

3:55 p.m. - 4:20 p.m.
Question Based Review- Industry’s perspective
Molly Rapp, Vice President, Regulatory Affairs, Fresenius Kabi USA

3:45 p.m. – 4:15 p.m.
Continuous Improvement in the Product Quality Lifecycle
John D. Ayres, MD, Senior Director, Product Safety Assessments, Global Patient Safety, Eli Lilly & Company (invited)

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

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

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

IG8: Blow Fill Seal

Interest Group Description: This IG session will discuss the following topics:

• Update on BFS Technical Report
• Use of regrind resin – pros, cons and regulatory perspective
• Resin updates – this is a tired topic, but still relevant due to more industry changes
• Interventions – what is typical/allowable?
• Viable sampling procedures – where and how often?
• Alert and action limits for particle counts

IG9: Packaging Science

Interest Group Description: The packaging science interest group session will have 3 presentations on the following topics:

Overview of Recently Revised PDA TR 43 – Glass Nonconformities - The original TR 43 was issued in 2007 and covered only tubular and molded vials. The revised version also includes a lexicon and discussion of the nonconformities of cartridges, ampoules, and syringes. This TR has become the leading reference for the quality of glass packaging components. The presentation will be made by a member of the PDA Task Force that authored the TR.

Extractables & Leachables (E&L) from Packaging & Processing Components – Regulatory expectations regarding E&L from both packaging and processing components have continued to evolve rapidly since the publication of the FDA’s Packaging Guidance in 1999. The PQRI has published best practices for the management of E&L for inhalation products (2006) and this has been used as the basis for submissions to FDA ever since. A PQRI TF is now developing procedures & best practices for a larger and more diverse segment of pharmaceutical products – ophthalmics and injectables. A member of the TF will discuss the status of this work and compare the practices developed to date with those for inhalation products.

New and Developing USP Chapters that Affect Packaging – Two new USP chapters on Elemental Impurities, 232 & 233, became official Feb. 1, 2013. These chapters affect not only drug products but also the packaging components used to contain and deliver these products. The USP has also discussed the development of chapters on both Extractables and on Leachables. A member of USP will provide an update on chapters that impact packaging.

IG10: GMP Links to Pharmacovigilance

Leader: John D. Ayres, MD, Senior Director, Product Safety Assessments, Global Patient Safety, Eli Lilly & Company

Interest Group Description:
The interest group was established in 2012. We have had the opportunity to meet for kick-off sessions in both the US and Europe. At the PDA/FDA Joint Regulatory Conference we will plan to identify topics of relevance that land squarely in this intersection. When a deviation or consumer complaint is identified, the first question for consideration is: What are the implications to patient safety? A model to engage in this assessment will be presented. We will also look at issues such as 3 Day Field Alerts, Drug Shortage, and developing product complaint and adverse event surveillance protocols to monitor change controls, stability findings, etc.

IG11: Clinical Trials

Leader: Galen Shi, PhD, Director, Global Clinical Trial Material Manufacturing, Eli Lilly and Company

Interest Group Description:
Sourcing Strategy and Vendor/Client Management in Clinical Trial Materials Supply Chain
The manufacture, packaging and distribution of clinical trial materials for biotech companies and big Pharmas can occur in both in-house manufacturing or outsourcing to CMO’s. The effective management of relationship with internal and external partners is of utmost importance to ensure on time delivery of quality materials for clinical trials. This meeting is targeted to discuss various models and strategies for innovation companies to engage manufacturing/packaging/distribution partners. Representatives from both industries (innovation research and contract CMO) are invited to discuss their experiences in working together to ensure the smooth operations of CT material supply chain.

IG13: Facilities & Engineering

Leader: Christopher Smalley, PhD, Director, BioSterile Validation, Merck and Company Inc.

Interest Group Description: This interest group will focus on discussing the topic of "Controlling Contamination".

• Facility Design – is your design robust enough to not only prevent contamination, but withstand cleaning processes?
• Facility Cleaning- balancing short-term cleaning needs with long-term objectives to preserve and maintain the facility.

Leaders: Jeffrey Hartman, Validation Manger, Merck Sharp & Dohme and
Michael Long, PhD, Director & Principal Consultant, ValSource, LLC

Interest Group Description:
This session will focus on the important topic of Drug Shortages and How the industry can apply risk management tools and techniques to identify and reduce risks along the supply chain. Two presentations, along with group discussions, will be provided. The presentations will include regulatory and industry views on how to tackle the issue as well as a framework for the Use of QRM in managing the risks Presented by PDA's QRM/Drug Shortage working group.

Jeffrey Baker, Deputy Director, CDER, FDA (invited)

Moderator: David Cummings, Associate Director for Quality, CDER, FDA

Moderator: Steven Mendivil, Executive Director, International Quality External Affairs, Amgen, Inc.

Session Description:
A discussion of FDA’s proposed plans for an Office of Pharmaceutical Quality (OPQ) including the rationale, concepts of operations and emerging areas of focus including quality metrics.

Session Description:
Our industry is experiencing a transition to globalization which encompasses regulations and compliance activities. Over a 5-10 year horizon economic forces will likely drive compliance, regulations and guidance to a significantly more harmonized status. Mutual recognition agreements, and the entry of FDA into PIC/S are evidence of this change. Despite this trajectory, regional, national and state regulations and guidance remain disparate, and opportunity exists for facilitating the transition to more convergent and harmonized guidance on sterile manufacture (terminal sterilization and aseptic manufacture). PDA task force leaders will report on their efforts to compare existing guidance in this important area.

8:00 a.m. – 8:30 a.m.
Questions and Answers/Discussion

8:00 a.m. – 8:30 a.m.
Questions and Answers/Discussion

8:00 a.m. – 8:30 a.m.
Questions and Answers/Discussion

8:45 a.m. - 9:15 a.m.
P4- A Patient's Perspective
Moderator:  Robert Dana, Senior Vice President, Education, PDA

Rick Roberts, Adjunct Professor, University of San Francisco

9:15 a.m. - 10:45 a.m.
P5- Compliance Update
Moderator:  John Finkbohner, Senior Director, Regulatory Affairs, MedImmune, Inc.

Session Description:
This session will feature the Compliance Directors from the FDA’s Centers and Office of Regulatory Affairs who will provide a short update on current hot topics in the compliance area. Significant FDA483 observations and other regulatory actions will be covered. Ample time will be provided for the Compliance Directors to participate in a Q and A session, taking questions from the floor. Don’t miss this opportunity to hear the latest in the compliance area; come prepared with your questions.

Panel Participants:

• CBER: Mary Anne Malarkey, Director, Office of Compliance, FDA (invited)
• CDER: Douglas Stearn, Deputy Director for Policy and Analysis, FDA (invited)
• CDRH: Steven Silverman, Director, Office of Compliance, FDA
• CVM:  Martine Hartogensis, Deputy Director, FDA
• ORA: Armando Zamora, Acting Director, OE, FDA

11:00 a.m. - 12:30 p.m.
P6- Center Initiatives
Moderator: Amy Giertych, Senior Director, Global RA, Baxter Healthcare

Session Description:
In this session we will hear directly from some of the agency's leaders with regard to their Center's current and future initiatives. 

Panel Participants:

• CBER: Karen Midthun, MD, Director, FDA (invited)
• CDER: Representative (invited)
• CDRH: Kimberly Trautman, Associate Director for International Affairs, FDA (invited)
• CVM: Bernadette Dunham, DVM, PhD, Director, FDA (invited)
• ORA: Steve Solomon, Deputy Associate Commissioner, FDA (invited)