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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.

On behalf of the International Probiotics Association(IPA) and our distinguished Chair for the day, Dr. Jessica ter Haar (née Younes), PhD, we would like to welcome you to this fourth edition of the Probiotic Workshop in DC.

Probiotics are unique in every way, from manufacturing processes, IP and ownership, to analytical requirements, nomenclature, and safety considerations. Regulatory bodies worldwide each interpret and deal with this uniqueness individually and in their own way. Due to the rapid evolution of the probiotic industry in the past few years, there are a surprising number of topics that have or will substantially affect the global regulatory landscape in the very near future. Topics that every company with a stake in the probiotic sector should be aware of.

Traditionally, the IPA Workshop in collaboration with USP has been US-centric and while that will continue for this edition, we have added some additional relevant presentations with international content for the benefit of the US stakeholders.

This one-day workshop will provide participants with valuable direct information from experts and also provide the opportunity to exchange on selected relevant issues for the US regulatory landscape. In addition to the more specific global challenges, we hope this can garner thought and provoke discussion and understanding to eventually clarify the regulatory approach which makes sense for the probiotic industry, and promotes safe and efficacious probiotic products for consumers in the U.S.

Please join the International Probiotics Association (IPA) in this collaborative workshop with U.S. Pharmacopeia (USP). Plenary Session chaired by Dr. Jessica ter Haar (née Younes), PhD, Director of Scientific Affairs for the International Probiotics Association.


AGENDA

8:30-8:45am

Welcome and State of the Probiotic Market

  • George Paraskevakos, Executive Director, International Probiotics Association
  • Dr. Jessica Ter-Haar, Scientific Affairs Director, International Probiotics Association


1. EDUCATION

9:00-9:30am

More Information Needed on Probiotic Supplement Product Labels

Dr. Daniel Merenstein


9:30-10:00am

The Evolutionary Ecology of Microbial Colonization of the Gut - Implications for Probiotics

Dr. Joe Alcock, Emergency Physician, Microbiome, and Evolutionary Medicine


10:00 – 10:30 am

A Degree Built by the Industry, for the Industry

Dr. Gena E. Kadar, DC, MS. MEdL, CNS. Dean, School of Nutrition at SCNM


2. PROBIOTICS AND THE REVISED DSHEA

10:45-11:15 am

Establishing an Adequate Intake for Dietary Microbes: Outcomes from an ISAPP Discussion Group

Dr. Mary Ellen Sanders, PhD, Consultant at Dairy & Food Culture Technologies


11:15-11:45 am

Follow up on Probiotics Master Files & NDI-related issues

Solange Henoud, Global Regulatory Affairs Director at Lallemand


11:45- 12:15 pm

FDA Perspectives and DSHEA

Steve Taves, Director, Office of Dietary Supplement Programs, FDA/CFSAN


3. TECHNICAL EVALUATION & REQUIRED TOOLS

1:15-1:45 pm

Validation of qualitative real-time PCR methods for molecular diagnostic identification of probiotics.

Dr. Hanan Shehata, PhD, Research Scientist


1:45-2:15 pm

Technology and Standards Committee- IPA's newest project

MehganStyke, Business Development Manager at Eurofins Group

IPA - TSC Co-Chair


2:15-2:45 pm

NDI Notification for Live Microbial Ingredients

Dr. Corey J. Hilmas MD, PhD, Chief Regulatory Officer, KGK Science


2:45-3:15 pm

USP Probiotic Activities Update

Dr. Kit S. Goldman, PhD, USP Staff - Director, Dietary Supplements and Herbal Medecines


4. TAXONOMY – A NECESSARY EVIL OR MARKETING OPPORTUNITY


3:15-3:45pm

Federal Trade Commission (FTC) Hot Topics and Law Enforcement Trends in the Health Product Industry

Carolyn L. Hann, Chief of Staff for Advertising Practices in the Federal Trade Commission’s Bureau of Consumer Protection, Division of Advertising Practices


3:45- 4:15pm

Taxonomy Reclassification-the blue-sky outcome

Prof. Dr. Michael Ganzle, Professor at University of Alberta



4:15-4:45pm

Probiotic Monograph – Challenges and Nomenclature, A Regulator’s perspective

Michael Steller, MSC, Unit Head, Natural and Non-prescription Health Products Directorate, Health Canada


4:45-5:20 pm

Historical Perspective

Kevin O. Gillies, Consultant, UAS Laboratories

Lawyer Perspective

Ivan Wasserman, Managing Partner, Amin Talati Wasserman, LLP

Commercial Implications

Nina Vinot, Area Sales Manager at PROBIOTICAL.


5:20 to 5:30 pm

CLOSING REMARKS


The IPA Probiotic Workshop in DC on Thursday October 31th, 2019.

Venue

Bethesda Marriott

5151 Pooks Hill Road

Bethesda, MD


* Accommodations – preferred pricing

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Date and Time

Location

Bethesda Marriott

5151 Pooks Hill Road

Bethesda, MD 20814

View Map

Refund Policy

No Refunds

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