Global Summit on Regulatory Science (GSRS18)

Global Summit on Regulatory Science (GSRS2018)

National Institutes for Food and Drug Control (NIFDC)
NIFDC Conference Hall
Beijing, China
September 26-27, 2018

Theme: Risk/Benefit of Dietary Supplements and Herbal Medicine in the Era of Data Science

The Global Summit on Regulatory Science is an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context.

Please fill out this form if you plan to attend GSRS18 in Beijing, China, September 26-27, 2018. There will not be a registration fee; however, participants are required to fill out the form in order to attend. Items marked with "*" are required.

GSRS18 Conference Coordinator:
Email: rbrooks@aralliance.org
Telephone (USA): (501) 397-2049 or (501) 580-5512

Local Contact:
Xingchao Geng, Ph.D, National Institute for Food and Drug Control (NIFDC)
E-mail: gengxch@nifdc.org.cn
Telephone: (China):+86-13661140092

Download the "Save the Date" flyer

Program Outline

  • Session 1: Regulatory Needs - Global Perspective in the 21st Century
  • Session 2: Challenges and Opportunities
  • Session 3: Toxicity and Safety Assessment
  • Session 4: Emerging Technologies and Data Analytics

Day 1 - September 26, 2018

8:00-9:00 am

Registration and Poster Setup

8:30-8:50 am

Opening Remarks

  • Deputy Director, China Food and Drug Administration (CFDA), CHINA
  • William (Bill) Slikker, Jr.
    Co-Chair, Global Coalition for Regulatory Science Research (GCRSR), USA

8:50 am – 1:00 pm

Session 1 – REGULATORY NEEDS – GLOBAL PERSPECTIVE IN THE 21 ST CENTURY

Session Co-Chairs

  • Li Bo, Director of NIFDC, CHINA
  • William Slikker, Director of NCTR/FDA, USA

8:50-9:05 am

Dietary Supplement vs Drug
Latasha A. Robinson, U.S. Food and Drug Administration (FDA), USA

9:05-9:30 am

Development of Regulatory Science in China
Changxiao Liu, Academician, Tianjin Institute of Pharmaceutical Research, Tianjin Binhai Center for Food and Drug Regulatory Science, CHINA

9:30-9:55 am

The Rules on Dietary Supplements in the European Union (EU)
Gudrun Gallhoff, Directorate-General, Health and Food Safety (DG SANTE), EU

9:55-10:20 am

Safety and Benefit Assessment of Food Supplements in the European Union
Valeriu Curtui, Head of the Nutrition Unit, EFSA, ITALY

10:20-10:45 am

Break

10:45-11:10 am

Recent Progress in Approval Systems for Herbal Medicines in Japan
Takashi Hakamatsuka, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences (NIHS), JAPAN

11:10-11:35 am

Food Supplements: Methodology Used in the Brazilian Regulation
Stefani Faro de Novaes, Sanitary Regulation and Surveillance, Brazilian Health Regulatory Agency (ANVISA), BRAZIL

11:35-12:00 pm

An Australian Perspective on Herbal Medicines Regulation—Growth and Opportunity in the Age of Data
Adam Cook, Complementary and Over the Counter Medicines Branch, Therapeutic Goods Administration (TGA), Australian Government Department of Health, AUSTRALIA

12:00-1:00 pm

Lunch (NIFDC Cafeteria)

1:00 pm – 5:00 pm

Session 2 – CHALLENGES AND OPPORTUNITIES

Session Co-Chairs

  • Elke Anklam, European Commission (EC), EU
  • Junzhi Wang, NIFDC, CHINA

1:00-1:25 pm

Assessing Public Health Risk for Novel Foods and Novel Food Ingredients
Scott Crerar, Science and Risk Assessment, Food Standards Australia New Zealand (FSANZ), AUSTRALIA

1:25-1:50 pm

Improving the Drug Review System to Accelerate New Drug Development in China
Zengjun (Alex) Xu, Chief Scientist, Center for Drug Evaluation, China National Drug Administration, CHINA

1:50-2:15 pm

The European Food Safety Authority’s Approach on Data for Safety and Benefit Assessment in the Area of Food Supplements
Marta Hugas, Chief Scientist, European Food Safety Authority (EFSA) and Valeriu Curtui, Head of the Nutrition Unit, EFSA, ITALY

2:15-2:40 pm

Botanical Drug Product Regulation in FDA
Jing Li, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA

2:40-3:05 pm

Break

3:05-3:30 pm

Challenges and Strategies for Safety Assessment of Health Food in China
Bo Li, Department of Food Risk Assessment, Institute for Food Control, NIFDC, CHINA

3:30-3:55 pm

Regulation and Safety Assessment of Supplemented Foods - A Canadian Perspective
William Yan, Director of the Bureau of Nutritional Sciences, Health Canada, CANADA

3:55-4:20 pm

Safety Assessment of Dietary Supplements Containing Medicinal Herbs in Korea
Jong Kwon Lee, Director, Toxicological Research Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety (MFDS), KOREA

4:20-4:45 pm

The future of the "Botanical Drugs" paradigm requires strong international regulatory harmonization
Cesar Compadre, University of Arkansas for Medical Sciences (UAMS), Arkansas, USA

4:45-5:30 pm

Panel Discussion

Day 2 - September 27, 2018

Session 3 – Safety and Quality Assessment

  • Primal Silva, Canadian Food Inspection Agency (CFIA), CANADA
  • Yan Huo, NIFDC, CHINA

9:00-9:20 am

A Need for Comprehensive Approach to Assess the Quality and Safety of Botanicals/Dietary Supplements
Ikhlas A. Khan, Director, National Center for Natural Products Research, University of Mississippi, USA

9:20-9:40 am

Mutational Signature Analysis for Molecular Cancer Epidemiology: the Example of Aristolochic Acid
Steven G. Rozen, Duke National University Singapore (NUS) Medical School, SINGAPORE

9:40-10:00 am

Dietary Supplements and Food Fraud
Franz Ulberth, Joint Research Centre (JRC), EU, ITALY

10:00-10:30 am

Break

10:30-10:50 am

Toxicological Evaluation of Dietary Supplements Using the Emerging and Conventional Methodologies
Nan Mei, National Center for Toxicological Research, Food and Drug Administration, USA

10:50-11:10 am

Concerns of Herbal Product-Induced Toxicity
Amy C. Brown, Department of Complementary & Integrative Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, USA

11:10-11:30 am

New Approaches and Special Consideration for Safety Assessment of Herbal Drugs
Xingchao Geng, NIFDC, CHINA

11:30-12:00 am

Panel Discussion

12:00-1:00 pm

Lunch

1:00-2:00 pm

Poster Session

2:00-2:20 pm

SESSION 4: DATA ANALYTICS AND EMERGING METHODOLOGIES

Session Co-Chairs

  • Weida Tong (NCTR/FDA, USA)
  • Marta Hugas (EFSA, EU, ITALY)

USP Botanical Standards – A Comprehensive Approach for Quality
Nandu Sarma and Nurisha Rush, United States Pharmacopeia (UPS), Rockville, Maryland, USA

2:20-2:40 pm

Establish Genomic Reference for Chinese Herbal Medicine Towards Health Food Safety
Professor Chang Liu, Institute of Medicinal Plant Development, Chinese Academy of Medical Science, CHINA

2:40-3:00 pm

Developing Safer Botanical Medicine Using Chemoinformatics Approaches
Shraddha Thakkar, National Center For Toxicological Research, Food and Drug Administration, USA

3:00-3:30 pm

Break

3:30-3:50 pm

Advancing Quality Control of Botanical Drugs Using Computational Methods: A Case Study of Panax Notoginseng
Xiaohui Fan, Vice Dean, College of Pharmaceutical Sciences, Zhejiang University, CHINA

3:50-4:10 pm

Emerging Technologies for the Quality Control and Activity Screening of Chinese Herbal Medicine
Qionglin Liang, Director, Modern Research Center of Traditional Chinese Medicine and Co-Chair of Department of Chemistry, Tsinghua University, CHINA

4:10-4:30 pm

Innovative Research on Herbal Inhalation Therapy
Ruchi Singh, Dev Sanskriti Vishwavidyalaya, Gayatrikunj-Shantikunj, Haridwar (Uttarakhand), INDIA

4:30-5:00 pm

Panel Discussion

5:00-5:10 pm

Closing Remarks

GSRS2018 Program Is Available for Download – Contains Bios, Presentation Summaries, and the tentative Program