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Probiotics: Challenges and Opportunities from Legal to Lab

Event Date: Tuesday, Apr 04, 2017 02:00 PM EDT

INSIDER Premium Series

April 4th 2017

Co-sponsored by:
CRN Informa

CRN Member Price:
$149*

*Discount subject to verification. Registrants that use the CRN member discount and are not members will be charged the additional $50 towards full registration.

Non-CRN Member Price:
$199


The probiotics category is one of the fastest growing segments of the dietary supplement industry. The Council for Responsible Nutrition (CRN) is continuing its popular webinar series with Natural Products INSIDER, and this webinar will explore key considerations when bringing probiotics to the marketplace. From the legal and regulatory implications of the revised new dietary ingredient (NDI) guidance on probiotics to challenges faced in the lab when testing probiotics, expert presenters will help clarify some of the complex questions surrounding these unique ingredients. The webinar will also examine whether a case can be made for the use of probiotics as a medical food for certain health conditions and address approaches to evaluating the safety of probiotics.

This webinar will help you:

  • Understand the potential impact of the revised draft NDI guidance and GRAS (generally recognized as safe) final rule on probiotics
  • Develop and apply a decision tree to assess probiotic safety
  • Recognize the complexities associated with probiotic testing, from identity to quantity
  • Identify opportunities for probiotics as medical foods

A Q&A period will follow speaker presentations.

Speaker and Topics:

  • Andrea Wong- Introduction
  • Ashish Talati- Impact of the revised NDI guidance (and final GRAS rule) on probiotics
  • Dr. Michael Pariza- Considerations for the safety assessment of probiotics
  • Tammy Blakemore- Challenges in probiotics testing
  • Sarah Roller- Probiotics in the dietary supplement – medical food interface
  • All Speakers- Q & A

Moderated by:


Andrea Wong, Ph.D.
Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN)

Dr. Wong is an integral part of CRN's science and regulatory affairs department, responding to emerging scientific and regulatory issues as well as advocating for science-based nutrition. Her regulatory expertise includes a working knowledge of international health claims, preparation of technical submissions to international regulatory agencies, and designing regulatory strategies for marketing products in global jurisdictions. Prior to joining CRN, she worked as a senior scientific and regulatory consultant for the consulting firm Intertek Cantox, formerly Cantox Health and Sciences International, in Ontario, Canada. Dr. Wong is published in scientific journals, including Regulatory Toxicology and Pharmacology. Dr. Wong earned her bachelor's of science in Life Sciences from Queen's University in Kingston, Ontario, and her doctorate from the University of Toronto, Ontario.


With:


Ashish R. Talati
Partner
Amin Talati Upadhye

Ashish R. Talati is a partner and chair of the food and drug practice at Amin Talati Upadhye. Mr. Talati helps clients safely navigate the minefield of U.S. Food, beverage, dietary supplement, drug, cosmetic and medical device regulations. Mr. Talati primarily counsels clients on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before FDA, FTC, Customs, USDA, DEA, and other federal agencies, and in court. Considered a creative and strategic partner by his clients, Mr. Talati works with companies all over the globe and is a trusted advisor at every step of the product life cycle, including product formulation, safety and efficacy studies, product launch, and ongoing marketing and sales. Mr. Talati has written extensively on topics related to new dietary ingredients (NDI) and has successfully filed many NDI notifications with FDA. Mr. Talati is widely regarded as one of the leading food and dietary supplement attorneys in the country.

Michael Pariza Michael Pariza, Ph.D.
Emeritus Professor of Food Science and Emeritus Director, Food Research Institute
University of Wisconsin-Madison

Michael W. Pariza, Ph.D., is an emeritus professor of food science and emeritus director, Food Research Institute, University of Wisconsin—Madison. He has authored or co-authored over 180 articles and publications, holds more than 25 U.S. patents, and is recognized by Thompson Scientific as one of the most "highly cited researchers" of the last two decades. Dr. Pariza has received numerous academic honors and awards including the Bernard L. Oser Food Ingredient Safety Award from the Institute of Food Technologists (IFT), the David Kritchevsky Career Achievement Award in Nutrition from the American Society for Nutrition, and the Kenneth A. Spencer Award for Outstanding Achievement in Food and Agricultural Chemistry from the American Chemical Society. He developed the principal guidelines for evaluating the safety of microbially derived food enzymes and microbial cultures that are used by government regulators and food enzyme manufacturers throughout the world.

Tammy Blakemore Tammy Blakemore
General Manager
SORA Labs

Tammy Blakemore guides SORA Labs with her proven track record for business management. With her passion to take SORA Labs to a new level of business success, she has become the driving force behind the company’s continued growth. Blakemore’s unique combination of science and sales makes her an invaluable asset to SORA Labs.

Sarah Roller Sarah Roller
Partner
Kelley Drye & Warren LLP

Sarah Roller is a partner in the Washington, D.C. office of Kelley Drye & Warren LLP and chair of the firm's food and drug law practice. For more than 25 years, Ms. Roller’s practice has focused on the representation of U.S. and global companies and industry trade organizations that are involved in the development, manufacture, labeling, and marketing of foods, beverages, dietary supplements and other health products. She represents companies in proceedings before FDA, USDA, FTC, TTB and state governmental bodies, and serves as counsel in litigation matters involving product safety, labeling and advertising regulation. Ms. Roller is a registered dietitian and received her bachelor’s of science from the University of Wisconsin-Madison and her Master of Public Health from the University of Minnesota. She received her Juris Doctor from The George Washington University. Ms. Roller has been recognized nationally as a leading practitioner by Chambers USA and selected as one of The Best Lawyers in America.


*All registration fees are non-refundable
*Content and speakers are subject to change