IPA’s popular one-day regulatory and scientific workshop is set to return to Washington DC for a third consecutive year.
Probiotics are unique. Whether considering manufacture, storage, stability or analysis, probiotics are different than other food and dietary supplement categories. As such, industry standards and guidelines for probiotics should not be written under their umbrella.
Careful consideration must be given when looking at how regulators include probiotics into categories and guidelines when creating definitions on how industry should conduct itself.
IPA offers this valuable workshop to proactively address such concerns. The program will concentrate on exchange, discussion and debate on how collaborating with the government agencies in the USA can make the probiotic sector appropriately regulated, considering its uniqueness all the while benefiting consumers of safe and efficacious probiotic products.
Hence the workshop presents an excellent opportunity in opening dialogue and possible collaborations in looking at how these friendly organisms can be considered within these regulations.
This event will take place on October 25th 2018 at the Bethesda Marriott. It will feature a host of speakers from the probiotic industry and from FDA, NIST and CBER. This year will also feature international speakers addressing current issues like the Nagoya Protocol and the upcoming Lactobacillus nomenclature revision.
This workshop has been made possible from our esteemed sponsors; we thank them for their valuable support.
Please join the IPA in this collaborative workshop with U.S. Pharmacopeia.
Plenary Session chaired by Dr Jessica Terhaar (Younes), Director of Scientific Affairs for the International Probiotics Association.
WELCOME & OPENING REMARKS
* Probiotic Market – An IPA Perspective
George Paraskevakos, Executive Director, International Probiotics Association
* Brazilian Dossier & Other Global Stories
Solange Henoud, IPA Regulatory Affairs Committee Chair
Global Regulatory Affairs Director, Lallemand health Solutions
* Health Canada Update – Probiotic Monograph & Challenges
Michael Steller, Unit Head, Health Products & Food Brands, Health Canada
* Taxonomy reclassification/lactobacillus genus
Dr Elisa Salvetti, Senior Post Doctoral Fellow, University of Verona (Italy)
* Nagoya Protocol – Dr Markus Wyss, Director Global Regulatory Affairs, DSM Nutritional Products Ltd
* Short Presentations & Panel Discussion – Next Generation Analytical Tools
– Mehgan Styke, Business Development Manager, Eurofins USA
– Dr Carmen Tartera, Research Microbiologist, Division of Molecular Biology, Office of Applied Research and Safety Assessment, U.S. Food and Drug Administration (FDA)
– Scott A. Jackson, Leader – Complex Microbial Systems Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology (NIST)
* Food Safety Modernization Act (FSMA)
Larisa Pavlick, VP – Regulatory & Compliance, United Natural Products Alliance (UNPA)
* Safety – How it relates to the new FSMA guidelines
Dr Amy Smith, IPA Codex Task Force Chair
Senior Manager, Regulatory & Scientific Affairs, DuPont Nutrition & Health
* USP update
* IPA Committee Updates
– Scientific Affairs Committee
– Manufacturing Committee
– Education & Communication Committee
* Closing Panel
– CHAIR – Ivan Wasserman, IPA Legal Counsel; Partner, Amin Talati Upadhye
– Dr Robert Durkin, Deputy Director, Office of Dietary Supplement Programs at CFSAN, FDA
– Dr Amy Smith, Senior Manager, Regulatory & Scientific Affairs, DuPont Nutrition & Health
– And more TBC
The IPA Probiotic workshop in DC on Thursday October 25th, 2018.
5151 Pooks Hill Rd, Bethesda,
MD 20814, USA
* Reservations for the event need to be made by individual attendees directly with Marriott Reservations at https://book.passkey.com/e/49727513 or by phone at 800.228.9290 or 301.985.7300. Special room rates are limited.
Registration, accommodation information and the draft agenda can be found at the following link:
Thank you again and hope to see everyone there,
Your IPA Team
Scenes from last year’s workshop in DC:
Below: Dr Cara Welch of the FDA; next photo top left: IPA’s Exec Director George Paraskevakos and other attendees.