Regulators involved directly in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) continue to view its voluntary, non-political status as a key component of its effectiveness and do not anticipate a move to change that status.
The impact of the voluntary nature of the interagency organization and its ability to operate outside the political sphere of influence was a focal point of the discussions at a session on PIC/S at the PDA/FDA annual conference in Washington, D.C. in September.
Setting the stage for the discussions were presentations by: ● Roche Europe/Japan External Relations Head Stephan Roenninger, who provided an industry perspective on FDA entry and the opportunities that PIC/S provides, and ● FDA’s liaison to PIC/S Brenda Holman, in which she reviewed how the organization works, its achievements and goals, and the challenges and opportunites in its path (see the IPQ Dec. 29 companion story, which includes an update on the developments at PIC/S November meeting in Cape Town, South Africa).
Also participating in the panel discussions that followed the two presentations was EMA’s liaison to PIC/S, Katrin Nodop. The EMA compliance and inspection official also plays an active role in the coordination process between the EU inspectorates, and is now focused on the coordination of the implementation of the new EU legislation on falsified medicines (IPQ “In the News” May 31, 2011). She is also chair of the group working on upgrading the EU GDP guidelines (IPQ “In the News” July 26, 2011).
Nodop opened the panel by explaining the close interrelationships between PIC/S and the European GMP/inspection program and initiatives.
She echoed Holman in highlighting the networking and training opportunities provided by PIC/S as its “most important and positive aspect…. For these areas, PIC/S is really excellent.”
Nodop linked this success to the organization’s voluntary, non-political status – setting the stage for the dialogue that followed.
[More from the dialogue at the PIC/S session is provided for subscribers here. Nonsubscribers can purchase the full story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]