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Voices of the Board

How PDA Supports the Regulatory Environment

by: Stephan Rönninger, PhD, Amgen (Europe) GmbH

Regulations provide the foundation for our industry to guarantee patients access to safe and effective medicines. Stepping back, let us look at the different types of regulations. In the legislative branch, the primary laws describe the value of certain regulations and the secondary laws outline the elements that need to be regulated. In the executive branch, countries issue “rules,” “regulations” or “directives” to describe “what to do” requirements. Related to these, “guidances” or “standards” outline “what to implement.” PDA volunteers help with these “what to do” and “what to implement” requirements through best practice documents, like our technical reports and points to consider papers, in addition to coordinating meetings and education courses focused on key regulatory topics.

Much of this work is coordinated through PDA’s Regulatory and Quality Advisory Board (RAQAB). Currently, RAQAB’s core of volunteers are supporting a variety of regulatory-focused initiatives. One involves development of a quality culture tool. Here, a team is doing a fantastic job of training regulators in the United States, European Union and United Kingdom, to better understand how industry actually operates beyond what is demonstrated by inspections and in regulatory dossiers. Another team is working on post-approval changes and lifecycle management (ICH Q12) while other volunteers are providing comments and feedback on the Annex 1 revision.

This work helps industry and regulators to continuously improve understanding of terminologies, regulations and expectations as well as facilitating innovation. PDA’s conferences, interest group meetings and educational courses support these efforts. When I ask members about attending a PDA “regulatory conference,” most refer to the ever-popular PDA/FDA Joint Regulatory Conference. But PDA offers other conferences addressing regulatory topics. When you read this article, PDA Europe will have just wrapped up its inaugural Pharmacopoeia Conference that brought together representatives of leading pharmacopoeias from around the globe to discuss opportunities for convergence. And, as more and more inspectors flag deficiencies related to outsourced operations and the supply chain, PDA has also organized a 360° view conference on the topic in Seville, Spain, for November.

Furthermore, PDA’s chapters are organizing meetings with local regulators in their respective regions to understand regulatory perspectives and, most importantly, facilitate dialogue. The Brazil and Singapore Chapters are currently planning such meetings and the Japan Chapter organizes a signature conference with regulatory partners each December.

Last, but not least, PDA Education offers courses at its Training and Research Institute (TRI) located at the U.S. headquarters in Bethesda, Md., and in different languages across Europe as well. In addition, PDA also offers in-house training opportunities adapted to the specific needs of companies and individual regulatory agencies.

As you can see, PDA offers a unique opportunity for members of industry and regulators to connect worldwide on these important topics and to share best practices and sound science in a globalized environment, that is, addressing the “what to do” and “what to implement.”

Please allow me to conclude on a personal note. This is my last year as a PDA board member. It has been, and remains, a pleasure driving PDA’s strategy by focusing on the third aspect of PDA’s mission: regulation. I want to close with a quote from my good friend, Tor Gråberg, as I believe these are the cultural elements for success in any regulated environment: “Collaboration, communication and trust.”