PDA’s Post Approval Change Innovation for Availability of Medicines Program (PAC iAM)

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Recorded Feb. 8, 2017

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"The challenge of managing various requirements and timelines to initiate manufacturing improvements has had the unintended consequence of stymieing innovation. As facilities and processes age, they are not keeping up with current technologies and practices, which in many cases lead to manufacturing stoppages and plant shutdowns and ultimately the very serious public health problem of drug shortages."
— Richard Johnson, PDA president

Managing the challenges of post approval change complexity is a big problem globally that not only hinders innovation and continual improvement but also can impact product availability and therefore, public health.

PDA has announced its program to reduce hurdles to pharmaceutical manufacturing innovation caused by disparate national regulations that discourage changes.

PDA’s PAC iAM program strives to identify — assess — and address current barriers to implementation of post approval changes that are intended to ensure continued operations, drive innovation and continual improvement. Addressing these barriers will better ensure and sustain reliable global supply and availability of product to patients through the entire commercial lifecycle of a product.

Join PDA task force members Denyse Baker, Emma Ramnarine, Melissa Seymour and Dr. Anders Vinther on Feb. 8 when they’ll discuss the task force objectives in tackling the issue of drug shortages.

PDA's task force has the following objectives:

  • Bring awareness to current challenges and enable stronger collaboration amongst opinion leaders and key stakeholders — within industry, regulatory authorities and other relevant stakeholder forums
  • Foster a science and risk-based approach to PAC management and regulatory decision making for global product quality, safety, and efficacy assessments
  • Encourage international convergence / standardization in PAC management in a manner that can foster and enable mutual reliance between regulatory authorities
  • Manage PACs through the use of an effective Product Quality Systems (PQS)

Attend this 90-minute interactive webinar to hear more about this initiative and to provide your feedback and ideas to the task force directly.

Who Will Benefit

  • Regulatory Affairs
  • Quality
  • Manufacturing Science and Operations
  • Research and Development
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Meet Your Presenters


Denyse Baker

Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment, CDER, FDA

Denyse Baker has 25 years of pharmaceutical industry and regulatory authority experience. Denyse started her career at Eli Lilly & Co. where she held leadership and management roles in engineering, parenteral manufacturing operations, and regulatory affairs both in the United States and Europe. She also worked for the FDA with responsibilities for the development and implementation of CDER Quality Systems for CMC Review.


Emma Ramnarine

Senior Director, Head of Global Biologics QC Network, Genentech/Roche

Emma Ramnarine is accountable for the global Biologics QC network strategy and commercial analytical control systems for the Biologics product portfolio — including lifecycle management, technology innovation, stability, raw materials management, analytical transfers, and QC oversight for CMOs. Emma is on the PDA Board of Directors, on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB), co-leads PDA’s QRM Interest Group and has led the development of several PDA Technical Reports.


Melissa Seymour

Vice President of Global Quality Control, Biogen, Inc.

Melissa Seymour is responsible for the comprehensive strategy and implementation for Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods worldwide at Biogen, Inc. Melissa has over 20 years of experience in the quality arena. Melissa has been highly active in the Southeast chapter of PDA for the last 5 years as a member of the local board, serving as Vice-President, President, and most recently, Past President. She was recently elected to the Board of Directors for PDA.


Dr. Anders Vinther

Chief Quality Officer, Sanofi Pasteur

Dr. Anders Vinther is accountable for the Quality strategy and cGMP compliance and quality performance for all vaccine manufacturing, testing release and supply worldwide at Sanofi Pasteur. He is a member of the Executive Committee at Sanofi Pasteur. He is active in the global dialog on a living quality ecosystem which includes how innovation and the availability of pharmaceutical drugs can be ensured in our complex world. Anders is past Chairman of the Parenteral Drug Association’s (PDA) Board of Directors and currently co-leading the PDA group working on technical lifecycle management.