FDA

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.

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.

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.

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.