IPQ: Staying Put, Always in Motion

While we may not have left our home offices in recent weeks (months!), IPQ’s staff has been anything but idle. Just in one recent week, we had four different multi-day meetings to attend to – all of which have made a substantial contribution to the dialogue on the issues on which they were focused. Our mission keeps us moving forward even when our energy flags a little.

A Week in the Life

On Monday and Tuesday, political, health policy, #regulatory and industry leaders from across Africa and around the world came together virtually to wrestle with the problems around the continent’s access to quality medicines – and to COVID #vaccines in particular – and how to expand its manufacturing capabilities. The summit was sponsored by the Africa CDC and African Union. The prominence of the participants and the intensity of the summit reflected a year of global health crisis and the realization that overcoming the crisis has to include addressing the access problems in Africa – which currently makes only about 1% of the vaccines it uses. The challenges that were well-aired during the two days are significant -- but the mandate and the will for action were palpable, and concrete next steps were laid out. So many individuals and organizations -- across the public and private sectors -- are rising to the challenges that we face together.

Of relevance to the discussions at the Africa conclave were those taking place at a very timely workshop hosted by #USP on controlling raw materials used in the manufacturing of #biologics. Top regulator, industry, and #pharmacopeia experts explored the critical raw material challenges that the fast-moving process and product #biotechnologies are presenting.

Not unrelated as well were the discussions among the top experts and thought leaders at two other meetings that took place: PDA’s annual visual inspection forum, and a workshop on drug/device #combinationproducts sponsored by #West. The dialogue at both again clearly reflected the pressing needs to identify and address the pressure points across the global regulatory landscape in these areas.

More to Come

And the pace of the discussions doesn’t ease. In the weeks that followed, #CASSS was holding its annual symposium on bioassays along with a China CMC strategy forum, and PDA a conference on robotics/automation. This last week in April includes an #excipient #GMP training workshop sponsored by #IPEC-Americas, PDA’s parenteral packaging conference, a two-day forum from #FDA on generic drug issues, and an #ISPE global pharmaceutical regulatory summit, where an impressive array of thought leaders weigh in.

It is a daunting list, and the rush of meetings where regulators and industry are sitting down together around the world to explore the current CMC/GMP challenges in view of the pandemic will continue unabated in May and June.

In the thick of it, here is our team's schedule of meetings and conferences for the coming weeks:

Pre-Filled Syringes East Coast Conference (Apr 26-27)

IPEC-Americas Excipient GMP Workshop (Apr 26-30)

PDA Parenteral Packaging Conference (Apr 27-28)

FDA Generic Drugs Forum (Apr 28-29)

ISPE Global Pharmaceutical Regulatory Summit (Apr 28)

ISPE Expert Xchange GAMP Workshop (May 11)

AAPS National Biotechnology Conference (May 17-20)

PDA Quality and Regulations Conference (May 18-19)

FDLI Annual Conference (May 18-20)

IPQ is doing all it can to facilitate this communication and help people stay informed through our coverage, as the feature story in our March issue exemplifies. In turn, the support we get from subscriptions is instrumental in our ability to make this contribution. Our reduced fees for new subscribers and for government agencies and suppliers make it easy to join us “Inside the Global Regulatory Dialogue” for the rest of 2021 and beyond. Just touch base with Jonathan Trethowan ([email protected]), who will be happy to answer any questions and extend a welcoming hand in coming on board.

We'll look forward to talking with you more "Inside the Global Regulatory Dialogue."