Avoid pitfalls, unpack issues, and brainstorm solutions for a smoother PMTA
Join in as our panel provides firsthand knowledge to help you navigate the exacting requirements of the FDA’s Center for Tobacco Products’ PMTA with best practices, common and not so common pitfalls, and the opportunity to engage with peers who are fully immersed in the process.
|Networking and one-to-one interaction with speakers, sponsors and attendees||✔||✔|
|On-site lunch and refreshment break networking at Troutman Sanders LLP in Richmond, Virginia||✔||✔|
|Engage with real-time Q&A||✔||✔||✔|
|Never-leave-your-desk access to live workshop||✔||✔|
|Live virtual access for your colleagues: unlimited (in recognition, this process requires a team)||✔||✔|
|Access to recorded workshop for 45 days after workshop||✔||✔|
Vice President of Federal Government Affairs
Swedish Match North America
Jim Solyst is the Vice President of Federal Government Affairs with Swedish Match North America. He has held senior positions in Washington DC based companies and associations, including the National Governors’ Association, American Chemistry Council, and the consulting firm ENVIRON International Corporation. During his over 30 years in Washington he has worked closely with federal agencies, including EPA, FDA and OMB. He has also worked with international organizations, including the UN, WHO and OECD.
Mr. Solyst is a member of the Food Drug Law Institute (FDLI) Tobacco Committee as well as the American Chemical Society Committee on Environmental Improvement. He is also a member of the National Academy of Sciences (NAS) Chemical Sciences Roundtable and served on the NAS Committee on Promoting Safe and Secure Chemical Management in Developing Countries. He also serves as an External Affiliate to the Johns Hopkins Risk Sciences and Public Policy Institute.
Mr. Solyst has written several articles and given numerous presentations on a range of regulatory science and public policy issues.
North America Nicotine (NAN)
Kevin Burd is the CEO of North America Nicotine (NAN) who exclusively distribute CNT Nicotine for North America. CNT Nicotine is the only nicotine manufacturer to carry 100% of the FDA approved products in the Pharmaceutical category with their impressive Drug Master File (DMF). Besides NAN, Kevin is the co-founder of Chemular, a regulatory consultancy dedicated to tobacco product compliance and registrations for North America and the EU. Chemular has registered several thousand products in Europe and has been progressing several US PMTA applications for the past several years. The company has an impressive world class team including ex-FDA officers and regulatory professionals from the Tobacco and Pharmaceutical industry.
Kevin has worked in the Ecig/Tobacco category for the past 7 years including consulting for top brands and manufacturers. Previously Kevin worked for the Medical Device and Pharmaceutical industry in executive, regulatory, and operations since 1994 for Baxter Healthcare and Mentor Biopolymers (now part of Johnson & Johnson).
Chief Regulatory & Compliance Officer
Josh Church is the Chief Regulatory and Compliance Officer for the JWEI Group, holder of the Joyetech, Eleaf and Wismec brands. He is instrumental in JWEI’s development of internal standards and oversees all compliance issues, especially for U.S. Food and Drug Administration and international regulations. Church leads AVER Labs, a dedicated e-cigarette development and safety certification laboratory, and Roots Holdings, a key player in the marijuana and CBD industries.
Troutman Sanders LLP
Bryan devotes his practice to representing businesses in disputes and regulatory compliance matters initiated by governmental agencies, including by state attorney general, and in other commercial litigation.
Bryan is an accomplished trial lawyer who has served as lead counsel in state and federal courts across the country.
A principal focus of Bryan’s practice is leading the firm's Tobacco practice in which he and other tobacco lawyers represent tobacco manufacturers, distributors, retailers and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving a federal or state governmental entity, commercial agreements and tobacco taxation matters.
Sr. Vice President of Scientific & Regulatory Affairs
Reynolds American Inc.
Mike Ogden is Senior Vice President of Scientific & Regulatory Affairs for RAI Services Company in Winston-Salem, North Carolina. He is responsible for regulatory research, compliance, governance, quality assurance, submissions, and scientific engagement for all Reynolds American tobacco operating companies and tobacco products. He holds B.S. degrees in both Chemistry and Applied Mathematics from Emory & Henry College, and a Ph.D. in Analytical Chemistry from Virginia Tech.
Previously, Mike was in charge of various R&D programs for R.J. Reynolds Tobacco Co., including those related to environmental tobacco smoke, measuring smoke uptake in smokers through the use of biomarkers, smoking behavior research, clinical studies, regulatory compliance activities and scientific and regulatory strategy.
Mike has been actively involved in various industry and non-industry organizations over many years, including the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA), the Association of Official Analytical Chemists (AOAC), the American Society for Testing and Materials (ASTM), the International Organization for Standardization (ISO), and the Global Tobacco & Nicotine Forum (GTNF).
PSI International Inc.
Dr. Samina Qureshi is a highly accomplished and progress-focused professional with more than 13 years of experience in managing, directing and serving as subject matter expert in critical health and pharmacovigilance projects for federal and commercial entities in the US and additional 8 years abroad. She is a physician and also has a Masters in Regulatory Science from Johns Hopkins University.
Currently Dr. Qureshi serves a leadership role at PSI International as Vice President of the Health Sciences Division with projects involving a mix of health sciences, technology, and social services expertise/guidance. She has experience with the premarket tobacco application (PMTA) and the modified risk tobacco product (MRTP) application pathway and developing guidelines for adverse experiences with tobacco products. She counsels clients on developing policies to confirm adherence to applicable regulations, provides compliance and implementation support for clients on emerging FDA CTP regulations, guidance and trends. Her expertise includes health sciences terminology and latest FDA drug safety protocols as well as Medical Dictionary for Regulatory Activities (MedDRA), World Health Organization Drug Dictionary (WHO-DD), and International Classification of Disease (ICD-9/10).
Dr. Qureshi is a published author in numerous journals and invited presenter at international conferences. Demonstrated strengths in program development and supervision, client relations and support, and strategic planning.
High Point Clinical Trials
Dr. Rusch is the President of the largest clinical research facility in NC, High Point Clinical Trials Center. Her expertise in Laboratory Medicine has given her a unique perspective in drug development and clinical pharmacology. This consultative approach to designing and executing highly complex studies has allowed High Point Clinical Trials to build an impressive track record working with highly regarded tobacco and nicotine client companies.
Dr. Rusch earned her Ph.D. from the Cleveland Clinic Foundation/Cleveland State University Consortium and completed a Fellowship in Laboratory Management at the Cleveland Clinic Reference Laboratory. Her training included the development, validation and deployment of novel biomarkers and safety testing throughout the 11-hospital system. Additionally, she has significant biomarker and drug development experience from leading IND efforts in the biopharmaceutical industry as well as operational expertise from well-known CROs.
As the President of one of the largest clinics executing studies required for the PMTA Dr. Rusch’s is highly versed in the use of appropriate biomarkers and optimizing these endpoints in clinical research.
Steve’s career spans almost 30 years in FDA-regulated industry in writing and project leadership roles. For the past 3 years this has included MRTPA and PMTA submissions. Key areas of his PMTA support include the steps needed to assemble the diverse set of required documentation, and then melding that with the company’s expertise into a coherent set of summaries, to produce a compliant submission that supports the authorization of the product.
Synchrogenix teams of experts provide a full range of regulatory and document-related services, including submission planning and management, QMS/SOP support, review of documentation and authoring of summaries across CMC, Nonclinical, and Clinical, Literature search and review, and Publishing and Submission of the full hyperlinked PMTA or MRTPA to CTP.