Live Q&A – PMTA Final Rule – What Does it Mean? – On-Demand

The PMTA Final Rule from the FDA is imminent, setting in stone the legal and (more importantly) the minimum requirements for a successful PMTA submission.

In order to support the industry and provide guidance on this ruling, we have put together a team of industry experts to field your questions and concerns around this. With experts from scientific, regulatory, legal, and manufacturing standpoints all represented on the panel, we are perfectly placed to help you work through any questions or concerns around your PMTA submission.

The panel:

  • David Lawson – CEO, Inter Scientific
  • Sally McGuigan – Principal Scientist, Hall Analytical
  • Patricia Kovacevic – Founder and Principal, RegulationStrategy


Panellists


Patricia Kovacevic – Founder and Principal, RegulationStrategy

Patricia offers counsel and compliance for a variety of organisations, including listed, Fortune 200 manufacturing/FMCG multinationals and AmLaw 100 law firms. She has extensive experience in regulatory, corporate and commercial law, legal department management and compliance, also having led teams of attorneys, scientists, and regulatory consultants. She also serves both global harm reduction and consumer needs. Across an array of specialities, she works closely with regulated industries in the nicotine replacement industry and has a coherent understanding of the legal implications of PMTA guidelines.


David Lawson – CEO, Inter Scientific

David specialises in pharmaceutical, medical device, nicotine & emerging category regulatory strategy with a focus on reduced-risk products and tobacco harm reduction.

He was responsible for the development, submission and approval of the first medically approved electronic nicotine delivery system (e-VOKE) and has been closely involved with the regulatory process ever since.

A biochemist by background, having worked in the pharmaceutical industry over 11 years, he have gained hands-on experience in all areas of product and regulatory life-cycle, from ideation to product licensing, IP, marketing and strategy.


Paul Holmes – ENDS Strategic Account Manager, Hall Analytical

Paul is the main point of contact at Hall Analytical for all testing related to the nicotine and cannabis markets. He holds a degree in Medicinal and Biological Chemistry.

Following several years in the laboratory, where he worked as an analyst on ENDS related testing, Paul now oversees ENDS commercial activities at Hall. His expertise lies in business development and technical/regulatory knowledge of the nicotine and cannabis industries.

He is a member of the CORESTA EVAP and HTP working groups, sits on an expert steering group with UKAS and the FSA for CBD Novel Food approval and regularly writes articles about nicotine regulation and testing for various publications


Moderator


James Teuscher – ENDS and E&L testing studies, North America, Hall Analytical

James is a high-energy account manager, who is responsible for ENDS and E&L testing studies in North America. Prior to Hall, James gained over 20+ years of experience serving in a variety of roles. These include project management, business development, and sales management that focused on analytical instrumentation and consumables at a variety of multi-national companies such as Phenomenex, Waters, Thermo Fisher Scientific, and Tecan. He is excited about the prospect of working with Hall and supporting the efficient and effective completion of our US customers projects.