iSpeak Blog

Hot Topics & Trends in Pharma Quality Systems & Regulatory Efforts

Frank Montgomery, PhD

With less than a month to go, we are now working with our industry and regulatory colleagues to finalize the sessions for the Quality Systems and Regulatory Track for the 2018 ISPE Annual Meeting & Expo. The program is looking fantastic.

We kick off the first day of the 2018 ISPE Annual Meeting & Expo on Sunday afternoon with a workshop on Lifecycle Process Validation with input from the FDA Office of Compliance. We then have seven educational sessions spread over the remaining 3 days with at least one regulatory agency representative presenting and contributing to every session!

Session Highlights

The topics are incredibly relevant to the shifts in both the environment and our company’s portfolios. We have a two-part session looking at the challenges and learning from accelerated developments through the critical inspection and launch phases, with contributions from:

  • Bristol Myers Squibb
  • Abbvie
  • AstraZeneca
  • Pfizer

With the approval of Q13 on Continuous Manufacturing as an ICH topic, we have Larry Lee, Q13 EWG Regulatory Rapporteur, providing his insights along with leading companies in this area Pfizer and Eli Lilly on global acceptance of this new technology approach.

A session reviewing the learning on preparedness for natural disasters informed by the impact of Hurricane Maria with input from drug shortage experts from Merck and FDA.

Drug-device combo product hot topics and trends are covered by Johnson & Johnson, Novartis, and FDA Office of Combination Products.

On the final day we finish with two sessions relevant to most companies:

  • How Do We Manage the Scientific and Regulatory Challenges with the Influx of New Modalities on Our Portfolios
    We are lucky to have two FDA representatives covering both CBER & CDER with a session led by Sarah Pope Miksinski and input from Amgen and AstraZeneca
  • Modernizing Pharmaceutical Quality
    This session will explore opportunities to use quality system performance to drive improvements and encompass the survey conducted by St Gallen on behalf of the FDA, case studies from pharma industry companies and input from Tara Gooen-Bizjak from FDA OPQ.

Right in the middle of all of these great sessions, we will have the highly anticipated Global Regulatory Town Hall. This year we have representatives from FDA, MHRA and ANVISA presenting on how the agencies are supporting the introduction of both new manufacturing technologies and new modalities not only in their regions but also what shared learning opportunities are happening across the agencies to facilitate global development of these challenging approaches.

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 2018 pharma event of the year!