The new US Presidential Administration could bring significant impact on MedTech and pharmaceutical regulations for manufacturers and product developers. Join our expert panel of scientists and FDA consultants as they explore the potential regulatory changes. Speakers will discuss changes in several key areas, including FDA policy shifts, warning and consent letters, vaccine regulation, Artificial Intelligence in healthcare, and the supply chain.
These experts will share firsthand knowledge of ongoing discussions and emerging trends, and help you prepare changes that will shape the future of the healthcare industry.
Attend this webinar and learn:
- What regulatory changes could be coming in 2025
- FDA focal points in the new administration
- Potential impact to the MedTech and Pharm industries
Register Now
Speakers:
Rona LeBlanc-Rivera, Ph.D. – Principle Consultant, Regulatory Affairs, Regulatory Compliance Associates
Rona has over 23 years of experience spanning the FDA and the pharmaceutical industry. She served as an FDA reviewer in chemistry, manufacturing and controls for biologics and generic drug applications, a regulatory affair professional, and as a pharmaceutical industry consultant, including support as primary liaison with FDA.
Anita Michael – Executive Principal Consultant, Pharma Compliance, Regulatory Compliance Associates
Anita has 24+ years of global regulatory and quality experience, including 16 years’ operating globally as a Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. She specializes in preparation, remediation and designing of training for individuals at all levels of an organization.
Thor Rollins – Biocompatibility Expert, Nelson Labs
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He is a participating member of multiple committees and plays an active role along with the FDA in developing standards, discussing biocompatibility methods, and voting on changes.
Alpa Patel, M.S., RM (NRCM) – Director of Lab Operations, Nelson Labs
Alpa Patel is a certified microbiologist and has been in the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. She plays an active role with the FDA and regulatory committees in developing/changing current standards.
