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DIA 2021 Global Annual Meeting


Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation)

Session Chair(s)

Veronika  Jekerle, PhD, RPh

Veronika Jekerle, PhD, RPh

  • Head of Pharmaceutical Quality
  • European Medicines Agency, Netherlands
Scientific and regulatory tools to allow for risk-based flexibility of quality data packages and their application to a number of different innovative products including complex generics, and COVID-19 vaccines, will be discussed in this session.
Learning Objective : Describe regulatory and scientific flexibilities in CMC aspects for product development as summarized in the recently published draft EU Toolbox guidance to support early access approaches; Discuss FDA’s perspective on the role of GDUFA II Pre-ANDA program on accelerating CMC development of complex generics; Discuss how such principles have been applied to innovative developments (COVID-19 mRNA vaccines); Assess future consideration, including lifecycle impact, by both regulators and industry.

Speaker(s)

Marcel  Hoefnagel, DrSc, PhD, MSc

EU Toolbox Guidance for PRIME Products

Marcel Hoefnagel, DrSc, PhD, MSc

  • Senior Assessor Biopharmaceuticals
  • Medicines Evaluation Board , Netherlands
Fang  Yuan, PhD

GDUFA II Pre-ANDA Program: A Tool to Accelerate CMC Development of Complex Generics

Fang Yuan, PhD

  • Chemist, OLDP, OPQ, CDER
  • FDA, United States
Lisa  DeCardenas

Applying CMC Acceleration with Considerations for Lifecycle Impact

Lisa DeCardenas

  • Regulatory Program Director
  • Genentech, A Member of the Roche Group, United States
Roger  Nosal, PhD

CMC Flexibility Applied to COVID-mRNA Vaccine Development

Roger Nosal, PhD

  • Vice President, Head of Global CMC
  • Pfizer Inc, United States
Dolores  Hernan Perez de la Ossa, PhD

Panelist

Dolores Hernan Perez de la Ossa, PhD

  • Quality Specialist - Pharmaceutical Quality Office
  • European Medicines Agency, Netherlands
Laurie  Graham

Panelist

Laurie Graham

  • Director, DIPAP, OPPQ, OPQ, CDER
  • FDA, United States