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

**This event is now full. To receive the on-demand version, fill out the form below.**

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.

Our panel (so far):

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

More info to follow. Places are limited to 50, so we ask that you preregister below. If you don’t make it to the event, it will be available on-demand.


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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.


Sally McGuigan – Principal Scientist, Hall Analytical

Sally has over 25 years of experience in gas chromatography supplementing that in the last 10 years with other chromatography/mass spectrometric techniques. She also has more than 10 years of experience in the field of ENDS (Electronic Nicotine Delivery Systems) and E&L (Extractables and Leachables). She is highly experienced in method development/validation, defining and designing study plans and final data review.

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.


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.