iSpeak Blog

Pharma Quality Systems & Regulatory Efforts Top Priorities & Hot Topics

Timothy J.N. Watson, PhD
Sarah Pope Miksinski, PhD
Regulatory Town Hall at the 2018 ISPE Annual Meeting & Expo

We are three months out from the 2019 ISPE Annual Meeting & Expo and we have finalized the titles and session topics for the Quality Systems and Regulatory Track. As director of this education track, I can tell you that the program is looking fantastic!

We kick-off on Sunday afternoon with the workshop Integrating Technology Adoption into Quality Risk Management and Continuous Improvement Strategies. The following speakers will take you through real-world examples and exercises to help you better understand the rationale behind change decisions and how to support changes by methodically presenting updated automation and human activities:

Peiyi Ko
Founder and Consultant (Owner)
KoCreation Design LLC
Brigitte Gubitz
Risk Management Expert
VTU Engineering
John T. Hannon, PE, CPIP
Global Automation & IT Lead
CAI

A tool designed to leverage an existing knowledge base and to enable you to put these concepts into practice will be provided.

We then have eight educational sessions spread over the remaining three days. We are working hard to include regulatory agency representative input, whether presenting or contributing to every session!  The topics are incredibly relevant to industry and regulatory interests and are well aligned with high priorities and “hot topics.”  We have a session looking at the experiences and case studies from accelerated development programs as well as a session (as a follow-on from last year’s annual meeting) specifically focused on patient centric dissolution specifications for extended-release solid oral products.  We were pleasantly surprised to see ow many proposals submitted for the conference overlapped on these topics; aligning on both agencies and ISPE membership interests.

Rounding out our track will be a line-up of sessions on:

  • Combination Products/Combination Therapies
  • Patient Centricity Amidst Increasing Global Complexity: Quality Overall Summary 
  • Pharmaceutical Quality System (PQS) Support of Lifecycle Management
  • True Lean Thinking – A Paradigm Shift to Reap Substantial Business and Patient Benefit
  • An Integrated Approach to Advancing Pharmaceutical Quality
  • Transition of Biologic Products from NDAs to BLAs

Teams leading critical ISPE initiatives are contributing across the program to provide you and your company with key resources in the areas of Pharma 4.0, Advancing Pharmaceutical Quality, and Product Quality Lifecycle Implementation (PQLI), including process validation, continuous manufacturing, knowledge management, patient focused quality standards, and accelerated medicinal products.

2019 ISPE Annual Meeting & Expo

In addition, you will have the opportunity to gain insights from the ICH Q12 Expert Working Group’s efforts in the areas of enhanced process knowledge, product understanding and risk assessment. You’ll hear about the research on quality metrics being conducted by St Gallen University in cooperation with the FDA and a proposed industry-led approach to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics.  Important take-aways from sessions on Pharma 4.0 will help your company to implement this strategic quality risk management process running over the whole product lifecycle.    

Throughout the entire education program, we are lucky to have seven US FDA speakers and session leaders representing multiple offices within both CBER and CDER, including:

  • Ramesh Sood, PhD, Office of New Drug Products, CDER/FDA
    • Co-leading the session Patient Centricity Amidst Increasing Global Complexity: Quality Overall Summary in the Quality Systems and Regulatory Track
  • Ahmed Zidan, PhD, Office of Pharmaceutical Quality, CDER/FDA
    • Leading the session Patient Centric Drug Development Through 3D Printing/Additive Manufacturing in the Innovation Forum

We will also have the event favorite, The Global Regulatory Town Hall, with this year’s theme Advancements and Opportunities in Recognition. This is your chance to be a part of an open discussion on global issues relevant to the pharmaceutical industry and regulatory agencies. This highly interactive panel discussion will focus on updates on key international convergence issues and feature global regulators representing multiple agencies including US FDA, Medicines and Healthcare products Regulatory Agency (MHRA), Centre for Food & Drug Inspection (CFDI), and the World Health Organization (WHO). 

As you can see, we have a packed agenda of highly topical subjects across the quality and regulatory spectrum presented from a balanced regulatory and industry perspective. Don’t miss the opportunity to attend the biggest, most insightful pharmaceutical event of the year!

Learn More & Register