That’s a wrap. Literally. The Regulatory Affairs Professionals Society (RAPS) Convergence 2017 wrapped up last week from the National Harbor in Washington D.C. and Amplexor Life Sciences was there to learn from regulatory bodies, start conversations and to offer solutions related to language services, regulatory, quality and compliance.
The annual RAPS gathering is the preeminent regulatory conference in the United States, so, of course, Amplexor was there in full force. This year’s exhibit hall was “first-rate,” according to Amplexor’s Vice President of Sales & Sales Training Bob Muzerall. “It would have been a misstep for any organization in the industry to sit this one out,” he added.
Opening the festivities, this year’s keynote was delivered by FDA Commissioner, Scott Gottlieb who highlighted the agency’s push to improve and streamline the clinical trial process. Mr. Gottlieb promoted the use of new tools in clinical trial design and offered his preference for “seamless” trials as an alternative to the traditional phase I, II and III paradigm.
These ideas floated by the commissioner would obviously have sweeping implications for drug and device companies as well as CROs in terms of process, study design and submissions. That’s why it is essential for companies under the eye of the FDA to get their documents in order, says Muzerall.
“What I learned over the past few days is that there are a lot of companies out there handling their documentation in a manual fashion. They’re using spreadsheets but they’re looking to become more efficient,” he said. Amplexor’s Life Science Suite does just that, it centralizes data and documentation and streamlines the submissions process globally, he added.
The event drew regulatory bodies from all over the world including the European Medicines Agency (EMA); the World Health Organization (WHO); the Pan American Health Organization (PAHO); the Health Surveillance Agency, Brazil (ANVISA); the Pharmaceuticals and Medical Devices Agency, Japan (PMDA); the Medicines and Healthcare products Regulatory Agency, UK (MHRA) and others. RAPS Convergence 2017 was well attended by the private sector as well with a strong presence from pharma, medical device, CROs, consultants and providers to industry.
The event also offered myriad presentations and workshops on everything regulatory from 510(k) developments to strategy for biologics.
RAPS Convergence 2018 will be in Vancouver, British Columbia. Amplexor Life Sciences hopes to see you there.