Skip To The Main Content

Voices of the Board

Another Year of Reg Collaboration

by: Emma Ramnarine, Roche/Genentech

PDA has started off the first quarter of 2019 with a plethora of regulatory activities. As a member of the Regulatory and Quality Advisory Board (RAQAB), I am proud to continue PDA’s leadership in collaborating with global regulators and pharmacopeias.

But first, I want to welcome PDA’s new Director of Regulatory Affairs, Ruth Miller. I, along with the rest of RAQAB, am excited she is bringing her broad experience base to PDA and look forward to working with her as we move forward with PDA’s regulatory agenda in 2019.

First, PDA collected comments through Feb. 28 for the PIC/S revised draft guidance, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. PDA happily assisted with consulting with stakeholders on specific questions relating to the proportionality, clarity and implementation of the guidance’s requirements. And speaking of data integrity, do not forget to register for the 2019 PDA Data Integrity Workshop following the 2019 PDA/FDA Joint Regulatory Conference in September.

PDA has also been collecting data from a survey on technology transfer practices. These results will be summarized in the Technology Transfer Interest Group session at the 2019 PDA Annual Meeting. The editors of the PDA Letter also plan to publish these results in a future PDA Letter InfoGraphic.

As far as technical reports, PDA plans to remain prolific in this space. One of the technical reports to be published this year touches on a hot topic for both industry and regulators: product lifecycle and post-approval change management. It will supplement ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, and the latest global thinking and concepts on post-approval change management by providing practical application solutions and examples. It has been a unique challenge for the technical report team to author a report for such a dynamic and constantly evolving topic—it has surely tested their ability to adapt!

Another eagerly anticipated technical report covers regulatory requirements for excipients. In 2011, the EU Falsified Medicines Directive required manufacturers to use formalized risk assessments to ensure excipients are suitable for use in products. We expect this technical report to clarify this area. I can tell you that the technical report team has been hard at work with teleconferences even going into the evenings for our U.S. colleagues!

Of course, PDA does not plan to rest on its laurels when it comes to working with regulators. You can expect to see continued engagement, commenting, new task forces and other global regulatory activities as we continue into 2019.