Connecting People, Science, and Regulation

The Parenteral Drug Association (PDA) focuses on connecting people, science, and regulation. For more than 60 years, PDA members have been active in responding to and driving implementation of global regulatory initiatives. Association members did not recently discover what the “c” in cGMP stands for; they have been actively defining and shaping it for many years. Nowhere is this commitment and energy more in evidence than at the PDA/FDA Joint Regulatory Conference, which will be held for the 23rd year, on Sept. 16-18 in Washington, D.C.

An objecive indentified in PDA’s Strategic Plan—Regulation—states: “Our regulatory activities are scientifically and technically focused, and current information is communicated to our members.” The organization supports this strategy with several criteria, including the provision of science- and technology-based input on regulations and guidelines related to PDA strategic areas, utilizing PDA’s volunteer and membership base. The organization maintains valuable and effective relationships with global regulators and educates members on current expectations.

Over the past six decades, PDA members have commented on every key cGMP regulation and guidance. PDA has hosted joint conferences with regulators, provided specialized training to regulatory authorities, and included regulatory officials in its processes for developing technical reports. This activity led to the creation of the PDA/FDA Joint Regulatory Conference nearly 25 years ago. It did not take long for this conference to become one of the most important annual events hosted by PDA for its members. Overall meeting attendance and the number of attendees and speakers representing not just FDA, but regulatory bodies from around the world has grown each year.

The 2013 PDA/FDA Joint Regulatory Conference: Driving Quality and Compliance throughout the Product Life Cycle in a Global Regulatory Environment, opens with a business imperative. Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER) will provide regulatory perspective, and Daniel Kraft, MD, executive director of FutureMed, will provide industry insight on the status of quality systems, quality by design, and drug shortages. The conference will conclude with information about FDA initiatives from representatives of CDER, the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA).

The conference offers four plenary sessions:
• The Quality Culture & Partners session explores ways to implement quality culture, how the culture impacts the effectiveness of a quality system, and highlights significant indicators of a weak quality culture.
• In the Understanding Good Manufacturing Practices session, speakers will
discuss how safety and efficacy is assured by routine adherence to the quality assurance and manufacturing control practices embodied in the GMPs.
• A Patient’s Perspective is designed to offer insight from a patient--someone who can help drug development professionals focus on their mission by expressing how drug products have helped save lives.
• In the Compliance Update session, compliance directors at each FDA center will report on current topics in the compliance arena.

The 2013 PDA/FDA Improving Investigations Workshop follows the conference on Sept. 18-19. Here, FDA specialists and industry experts discuss the root causes of poor investigations. As you may know, these are among the top inspection observations globally. Finally, extend your learning in one of six courses offered by PDA’s Training and Research Institute.

These activities exemplify PDA’s tireless focus on “Connecting People, Science, and Regulation.”

About the Author
Richard Johnson is president of the Parenteral Drug Association (PDA).