2017 ISPE/FDA/PRQI Quality Manufacturing Conference

The 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offers a new and exciting format where participants will be able to interact directly with pharmaceutical industry and regulatory leaders in a four-series workshop rotation.  Today’s blog focuses on the details of Linking Quality to Clinical Relevance, one of the four core workshops taking place at the conference.

Regulatory officials and the pharmaceutical industry have been exploring how clinically relevant specifications (CRS) might be of value with regards to patient safety.  Varying positions on these topics have been proposed:

  • Using acceptance criteria based on clinical relevance, instead of process capability or manufacturing process control
  • Intentionally adding variability into clinical trials
  • Setting specifications based on limited batch data and/or commercial manufacturing experiences
  • Utilizing ICH guidance based safety projections

Questions remain on the extent of clinically relevant specifications boundaries including:

  • Experiences within the clinic and commercial scale
  • Defining the degree of risk
  • Would clinical relevant specifications might be more relevant over the product lifecycle.

The Linking Quality to Clinical Relevance workshop at the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offer attendees the opportunity to discuss experiences and identify solutions to address the challenges of implementing the use of clinically relevant specifications.

Workshop Objectives:

  • Develop new ways of thinking about setting drug substance and drug product specifications
  • Educate and share with pharmaceutical industry professionals and global regulatory agency officials about the risk and impact to public health and business on non-clinically relevant specifications
  • Facilitate pharmaceutical/biotech industry to implement the tools and strategies to achieve clinically relevant specifications for future drug products


  • Susan Berlam, Senior Director, Regulatory CMC, Pfizer Inc.
  • Sarah Pope Miksinski, PhD, Director, Office of New Drug Products; Director (Acting), Office of Surveillance, FDA/CDER/OPQ
  • Shrinivas (Cheenu) Murti, PhD, Senior Director Global CMC Regulatory Affairs, Merck & Co., Inc.
  • Daniel Peng, PhD, Senior Principal Scientist/Director, Shire
  • Paul Seo, PhD, Director (Acting), Division of Biopharmaceutics, FDA/CDER/OPQ/ONDP

Tired of listening to talk after talk?  Learn why the 2017 IPSE/FDA/PQRI Quality Manufacturing Conference will be unlike any pharmaceutical industry conference you’ve experienced before!

Register Now for 2017 ISPE/FDA/PQRI Quality Manufacturing Conference

2017 ISPE/FDA/PQRI Quality Manufacturing Conference

The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges on key issues. Sessions are designed to encourage open discussion about current FDA priorities and industry-critical quality initiatives.