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Bethesda Marriott

5151 Pooks Hill Road

Bethesda, MD 20814

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One day regulatory and scientific workshop for Probiotics.

Probiotics are unique in every way, from the manufacturing processes, storage & stability needs as well as the analytical requirements to touch but on a few areas. Careful consideration must be taken when it comes to looking at how regulators view their inclusion into guidances and guidelines. Probiotics cannot be blanketed into all the other food and dietary supplement categories when creating definitions on how industry should conduct themselves.

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 one day workshop 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.


Please join the IPA in this collaborative workshop.

Plenary Session chaired by Dr Daniel Merenstein, Professor Georgetown University, Director of Research Programs Family Medicine, Georgetown University Medical Center, Department of Human Science, School of Nursing and Health Studies


Confirmed Agenda:

(1) 8:40-9:10am Market Data – Consumer Perspective from the Kantar Media survey

By George Paraskevakos, Executive Director, International Probiotics Association

(2) 9:10-9:50am USP Probiotics Expert Panel – Major Tasks

- Dr David Keller, Vice-President of Scientific Operations, Ganeden; Chair of IPA Working Group on Best Practices Guidelines

- Dr Mary Ellen Sanders, Consultant, Dairy & Food Culture Technologies; Chief Science Officer, International Scientific Association for Probiotics & Prebiotics

(3) 9:50-10:20am FDA Update

By Dr Cara Welch, Senior Advisor, FDA's Office of Dietary Supplement Programs, FDA

COFFEE BREAK 10:20-10:35am

(4) 10:35-12:15 Short presentations followed by a Panel Discussion – Next Generation Analytical Tools

- Dr Carmen Tartera, Research Microbiologist, Division of Molecular Biology, Office of Applied Research and Safety Assessment, U.S. Food and Drug Administration

- Scott Jackson, Leader, Complex Microbial Systems GroupNIST, National Institute of Standards and Technology

- Dr Buffy Stahl, Global Business Development Leader – Probiotics, DuPont Nutrition & Health; IPA Technical Committee Chair

LUNCH BREAK 12:15-1:10pm

(5) 1:10-1:40pm USP Probiotic Standards

By Dr Seong Jae Yoo, Scientific Liaison, Science-Dietary Supplements and Herbal Medicines, USP

(6) 1:40-2:10pm FDA Perspective on INDs and Probiotics

By Sheila Dreher-Lesnick, Office of Dietary Supplement Programs, FDA

(7) 2:10-3:50pm IPA Committee Updates

i. Regulatory Affairs Committee – IPA Guidelines to Qualify a Microorganism to be Termed as Probiotic;

By Solange Henoud, IPA Regulatory Affairs Committee Chair; Global Regulatory Affairs Director, Lallemand health Solutions

ii. Manufacturing Committee

By Kevin Mehring, IPA Manufacturing Committee Chair; President & CEO, UAS Labs

iii. Technical Committee

By Dr Buffy Stahl, IPA Technical Committee Chair; Global Business Development Leader – Probiotics, DuPont Nutrition & Health

iv. Education & Marketing Committee

By Maile Combs, The Nature’s Bounty Company; and Christina Phelps, Amway; IPA Education & Marketing Committee Co-Chairs

v. Codex Task Force

By Dr Amy Smith, IPA Codex Task Force Chair; Senior Manager, Regulatory & Scientific Affairs, DuPont Nutrition & Health

(8) 3:50-4:45 Closing Panel: What are some regulatory changes on the horizon and how will they affect the industry?

- Solange Henoud, Global Regulatory Affairs Director, Lallemand health Solutions

- Sheila Dreher-Lesnick, Office of Dietary Supplement Programs, FDA

- Dr Buffy Stahl, Global Business Development Leader – Probiotics, DuPont Nutrition & Health

- Dr Amy Smith, Senior Manager, Regulatory & Scientific Affairs, DuPont Nutrition & Health

- Ivan Wassermann – IPA legal counsel

- Dr Cara Welch, Senior Advisor, FDA's Office of Dietary Supplement Programs, FDA


(9) 4:45-5:00 Close out remarks and thank you


* Reservations for the event need to be made by individual attendees directly with Marriott Reservations at 800.228.9290 or 301.985.7300 or online via https://aws.passkey.com/e/49410140. Special room rates are limited.


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Bethesda Marriott

5151 Pooks Hill Road

Bethesda, MD 20814

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Refund Policy

No Refunds

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