The PDA/FDA Joint Regulatory Conference is now in its 27th year. This important conference provides a forum for discussions centered on the requirements that assure the availability and delivery of high-quality medical products, and offers an opportunity to hear about the latest issues in the regulatory, quality, supply, and compliance areas for medical products in an ever-evolving landscape. Attendees will hear straight from regulators and industry leaders about how to meet the challenges of developing, manufacturing, and assuring availability and safe supply of necessary medicines to serve the patient.
In keeping with the focus on putting patients first, this Conference will explore topics that ensure innovation, quality, compliance, and a continued supply of important drugs, biologics, and combination products. The past year, 2017, presented the medical products industry with many challenges in assuring a continued supply of necessary medical products. These challenges included major natural disasters and disruptions that affected manufacturing and supply chains. Combined efforts of industry and regulators were necessary to assure uninterrupted supplies of safe and high-quality products in the face of such challenges.
It light of the fact that it is nearly 10 years since the heparin incidents, the Conference will address issues affecting the supply chain and the evolving regulatory landscape. Solutions that have been successful in keeping the supply chain secure, assuring quality of medicinal products, and achieving compliance with regulatory and quality expectations as they continue to evolve, will also be explored.
The Conference program will include discussions on combination products, aging facilities, quality risk management, post-approval changes and life-cycle management, process validation, and challenges of regulatory application submissions. Attendees will also learn about hot topics, such as aseptic processing, managing enforcement actions (e.g., consent decrees), inspection updates, quality systems, and quality trending, among others.
Sessions will include many case studies and practical solutions to current supply challenges, such as shortage prevention and disaster recovery, management of contract manufacturers, supplier oversight, supply chain challenges for innovative products (e.g., cell and gene therapy), and supply chain safety. The traditional and ever-popular presentations of each of the FDA’s medical product areas to discuss program specific initiatives and compliance updates will also be included. There will also be speakers from other regulatory agencies and global industry leaders who will explore the issues facing companies that operate globally.