API and Clinical Trails Training

by | Jun 18, 2020 | API and Clinical Trails, Blog

Shankar Seetharaman is a Qualified Person with many years of experience in API auditing and clinical trials supply. He currently is the Managing Director of Pharmanswers Ltd which is a consultancy with a proven track record of providing quality and regulatory support for the pharmaceutical industry.

The key learning points for the API presentation include understanding what an API is and how it is regulated within the EU including those that are imported from outside the EU.

The key learning points for the clinical trials presentation include understanding how clinical trials are conducted within the EU and the regulations surrounding them.

Testimonials

Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
API and Clinical Trails Training