Regulatory Affairs

June 12, 2020

Published by Meranda Parascandola at June 12, 2020

The Odd Couple- Part 1: Characterization – He’s Never Developed a Regulatory Submission and She’s Never Submitted One.

For the purposes of this blog series, it will be necessary to produce an admittedly unbalanced summary that shortchanges some sections of the Quality Module but that includes considerable discussion of other sections that can largely influence the ultimate success or failure of an application. I have therefore focused discussion on selected aspects from a remarkably diverse and technical exercise, which is the production of the CTD Quality Module.

July 31, 2020

Published by Meranda Parascandola at July 31, 2020

Expedited Drug Development with James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.

August 7, 2020

Published by Meranda Parascandola at August 7, 2020

Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda, Brian and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.

August 14, 2020

Published by Meranda Parascandola at August 14, 2020

Effective Strategies for Early Stage Drug Development with Judy Magruder

InPharmatics’ Senior Program Management Consultant, Judy Magruder joins the show to share her vast experience consulting with biopharmaceutical product development organizations. In this episode, Ed, Brian, Meranda and Judy discuss how to approach early stage drug development, how to be flexible in the wake of regulatory challenges, instances where companies should pivot and the vital need for effective communication.

August 21, 2020

Published by Meranda Parascandola at August 21, 2020

Quality Assurance and Auditing in the Age of Covid-19 with Bettina Kaplan

Design Space InPharmatics Senior Quality Assurance Consultant, Bettina Kaplan joins the show to share her experience with quality assurance and auditing in the pharmaceutical industry. In this episode, Ed, Brian, Meranda and Bettina discuss the impact that Covid-19 has had on auditing and how it has shifted the industry to focus on virtual audits. Bettina speaks to trends in quality auditing and the risks associated with not having audits done regularly.

August 28, 2020

Published by Meranda Parascandola at August 28, 2020

Pharmaceutical Regulations in CMC with Dr. Catherine Bernard

DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.