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Interactive Summit: Sharing Both Industry and Regulator Perspectives

George P. Millili, PhD
Interactive Summit: Sharing Both Industry and Regulator Perspectives

Please join me at the 2019 ISPE Global Pharmaceutical Regulatory Summit, being held at the Bethesda North Marriott in Bethesda, Maryland December 5-6, 2019. The theme for this year’s summit is “Igniting Innovation in Development & Quality During Lifecycle Management”. I am pleased to serve as this year’s summit Co-Chair, and believe we have assembled a very experienced international planning committee representing both industry and regulators. Our team has met and has identified the key areas impacting our industry in the areas of “Innovation and Quality”.

The intention of the summit is to address quality, technology, operations, and regulatory affairs facets of pharmaceutical innovation. The sessions being designed for this event are geared towards personnel of all levels of experience in the Technology/Engineering, Quality, Operations and Regulatory Affairs areas. We are fortunate to have Dr. Janet Woodcock (Director of the Center for Drug Evaluation and Research, FDA) to kick off the program and set the tone for the summit. The meeting has been designed to be interactive, sharing both industry and regulatory perspectives. In addition, adequate time has been allotted for Question & Answer periods with program speakers and networking opportunities with your peers.

A brief summary highlighting some of the planned sessions is as follows:

  • ISPE Advancing Pharmaceutical Quality (APQ) initiative: The ISPE APQ team has assembled several sessions with presentations followed by Q&A. This team hopes to cover areas such as: Year #3 St. Gallen Research Feedback on the FDA-sponsored Quality metrics program; Case studies and discussions on the business case for Quality and a report on the latest progress of the team on APQ with Culture underpinnings.
  • ISPE Continuous Manufacturing initiative: Industry representatives and regulators intend to discuss the latest draft of the FDA Continuous Manufacturing “draft guidance” with the intent of sharing industry thoughts and promote discussion on the guidance.
  • ISPE Accelerated Development initiative: The team intends to share with you and summarize some of the content they have developed and continue to develop on the topic via white papers. The session will cover both regulatory and CMC challenges faced with these types of filings. They will share risk-based examples utilized and summarize some of the regulatory tools currently available. Case studies will also be provided outlining the approaches and challenges faced and the types of regulatory interactions they have encountered. The concepts presented in this session will be applicable to both small and large molecules.
  • Biotechnology session: A session will be devoted to the development and quality aspects of Biotechnology development with an emphasis on ATMP (i.e. PQS challenges, Validation, PAT etc.).
  • Pharma 4.0 session: ISPE has been very active in discussing, influencing and sharing the future technologies, skills and approaches our industry needs to consider to advance and be successful in supplying new and novel, safe products with high-quality standards to our patients. This session will be devoted to some presentations and discussions in this area.

In addition to the opening plenary session, three other plenary sessions are planned to cover: Case studies with a Regulatory Focus of Innovation – International regulator and Industry emerging technology interactions and the closing Plenary will be devoted to an interactive international session on Global Reliance/Harmonization with a distinguished international panel of industry and regulatory leaders.

I look forward to interacting with you at this summit in December and hearing your perspective on these important key topics.

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