PDA Letter Article

Exciting Lineup of Speakers at the 2019 PDA/FDA JRC

by PDA/FDA Joint Regulatory Conference planning committee


Peter Marks, MD, PhD, Director, CBER, U.S. FDA, Louis Schmukler, Senior Vice President and Global Product Development and Supply, Bristol-Myers Squibb, and Marschall S. Runge, MD, PhD, Executive Vice President for Medical Affairs, University of Michigan, will headline an esteemed lineup of keynote speakers at the 2019 PDA/FDA Joint Regulatory Conference.

These distinguished speakers will be joined by a slate of regulators and industry-leading speakers who will share their insights on how you can improve the continued supply of high-quality drugs, biologics, and novel combination products to patients.

The theme of this year’s conference is “Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision,” and the conference will explore the continuing development of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. Plenary and concurrent sessions will delve into the details through the assessment of the latest innovative technologies, regulatory expectations, and forward-looking perspectives, including:

  • CGMP challenges associated with cell and gene therapies
  • Combination products and connected care applications
  • Compliance updates and case studies
  • Data integrity remediation and an update on the associated PDA technical report
  • Designing aseptic processes to reduce quality risk
  • Effective internal and external audits
  • Evolving approaches to quality management systems
  • Improving deviation and failure investigations
  • Strategies for continuous improvement of facilities and equipment
  • Use of augmented reality and artificial intelligence in manufacturing

Attendees will also learn about hot topics, such as inspection updates, laboratory controls, rapid microbiological methods, optimizing regulatory submissions, conducting effective smoke studies, and quality trending. Multiple interest groups will meet to discuss in-depth regulatory and compliance issues.

Once again, the 2019 PDA/FDA Joint Regulatory Conference will explore the global regulatory issues facing the industry.

To learn more and to register, visit the PDA website!