Janeen Skutnik-Wilkinson, Biogen, (Interest Group Coleader) and Karen Ginsbury, PCI (Former Coleader) | Nov 06, 2017
PDA’s Pharmacopeial Interest Group has been active since 2011. Recently, we took some time to review the Pharmacopeial Interest
Group’s five-point mission statement and see how the interest group is meeting these five goals. Below are our findings:
Advocate globally for greater pharmacopoeial cooperation, harmonization (both prospective and retrospective) and working long term toward the ultimate goal of a single international publication
When WHO published a Good Pharmacopoeial Practices draft guidance, the interest group rapidly assembled a task force and sent in
general comments in a tight timeframe. Within one day of receiving our general comments, WHO asked for our detailed comments and
we sent those in. Clearly, the interest group has a voice and represents the general consensus of PDA’s membership.
Monitor compendial activities and publications and provide periodic reports to RAQAB and PDA members
If you take a look at the group’s PDA ConnectSM site, you will see that our members are kept abreast of updates through this medium.
But, there is also a call for members to make posts—so please start doing that. All posts are welcome.
Prepare position papers on compendial initiatives and proposals not being addressed by other PDA Committees
The interest group regularly discusses compendial concerns at face-to-face meetings at PDA’s Annual Meeting and Joint Regulatory
Conference with the U.S. FDA. Additionally, PDA is hosting its Pharmacopoeia Conference next May in Vienna, cochaired by Janeen
Skutnik-Wilkinson, Staff Associate Compliance & Standards, Biogen, and Susanne Keitel, PhD, Director, EDQM. The theme of
the conference is fast-tracking pharmacopeial convergence/harmonization and the future direction of pharmacopeias. We would like to publish more position papers on compendial initiatives, but that needs volunteer input, so reach out to us!
Represent PDA at the USP Stakeholders Forum
We do not always manage to get a PDA-specific person there, although, we try. But any PDA member planning to attend a USP forum is always
welcome to contact the interest group and let us know if they are interested in serving as a PDA representative. The interest group’s leaders
would work with such a volunteer on where PDA stands with issues under discussion at the meeting and how to obtain formal feedback.
Proactively identify compendial topics and advocate PDA’s position
We don’t always manage to do this, and we need help here, too. If you hear of a compendial issue, let the group know!
Additionally, this interest group recently gave an update to PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB), its Advisory
Board umbrella, summarizing the group’s activities. One of the actions identified was to obtain volunteers and “spread the word” among
PDA’s membership base, and this update is intended to achieve just that. Anyone wanting to become active in this interest group can
contact Denyse Baker at PDA and let us know what you would like to take on.
In summary, the interest group has been and continues to be active. It clearly has a place at PDA and is beneficial to members and to
RAQAB and the Board of Directors. There is a need to channel the group’s activities better and grow a set of committed industry volunteers
who work with pharmacopeias day in and day out and, therefore, can easily update the group. We hope to hear from those interested
in volunteering and we would be delighted to receive feedback from anyone with fresh ideas.
We also want to welcome Anette Yan Marcussen, the new coleader of the interest group. She replaces Karen Ginsbury, who is stepping
down. She looks forward to taking the interest group into 2018.