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Workshop IV: Pre-Release and Post-Release Regulation of Genetically Engineered Plants

    November 17, 2023-November 18, 2023
    9:00 am - 5:00 pm
    Department of Environment
    Dhaka, Bangladesh

The Agriculture & Food Systems Institute (AFSI), in partnership with the Department of Environment, Ministry of Environment, Forest and Climate Change, Government of Bangladesh, under the auspices of the South Asia Biosafety Program (SABP), conducted a workshop series titled “Origins of Biosafety Internationally, the Relevant Policies and Regulations in Bangladesh, and the Necessary Regulatory Process During Each Phase of Biotechnology Research, Development, and Release.” The purpose of these training activities was to engage with experts at the Department of Environment in Bangladesh who are involved with the biosafety regulatory system. This program aimed to help them better understand their regulatory responsibility and how to best work with developers of genetically engineered (GE) organisms. Biosafety compliance while working with GE organisms was discussed throughout this series of workshops.

The first workshop introduced the fundamentals of biosafety, with presentations on the history and context of biosafety, the development process for GE plants, regulatory responsibility, and biosafety obligations during GE plant development. The second workshop focused on the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from GE plants. The third workshop presented the structured approach to ERA, beginning with a scoping process called problem formulation. The fourth and final workshop provided a platform for discussing the considerations that inform the pre-release and post-release regulation of GE plants. This two-day technical training program for risk assessors delivered in-depth technical information about handling GE plants in laboratories during research, transporting plant material to contained facilities such as greenhouses, and regulating and conducting confined field trials. Through a series of presentations and exercises, participants gained a deep understanding of biosafety concepts associated with the handling of GE plants prior to and after release into the environment.

Speakers

Andrew Roberts, Ph.D.
Chief Executive Officer Agriculture & Food Systems Institute (AFSI)
Karen Hokanson, Ph.D.
Senior Manager, Scientific Programs Agriculture & Food Systems Institute (AFSI)
Rakha Hari Sarker, Ph.D.
Country Coordinator South Asia Biosafety Program (SABP)
Vibha Ahuja, Ph.D.
Senior Advisor South Asia Biosafety Program (SABP)
Aparna Islam, Ph.D.
Professor Brac University
Dil Afroj Moni
Program Officer South Asia Biosafety Program (SABP)

Agenda

Day 1

November 17, 2023 | 9:00 am - 5:00 pm

Time Topic Presenter/Facilitator
Opening Session
9:00 am Registration Ms. Dil Afroj Moni
Program Officer, South Asia Biosafety Program, Bangladesh
9:15 am Welcome and Introductions
Recap of Workshops I-III		 Prof. Dr. Rakha Hari Sarker
Professor, Dhaka University and Country Coordinator, South Asia Biosafety Program, Bangladesh
9:45 am Opening Remarks from the Agriculture & Food Systems Institute Dr. Andrew F. Roberts
Chief Executive Officer, Agriculture & Food Systems Institute, USA
10:00 am Tea Break
Technical Sessions 
10:30 am General Concepts for the Regulation of Research, Development, Transportation, and Handling of GE Plants Dr. Andrew F. Roberts
11:30 am Key Provisions for Pre-Release Biosafety Regulation in the Bangladesh Biosafety Guidelines Dr. Aparna Islam
Professor, Biotechnology Program, Brac University and AFSI Fellow, Bangladesh
12:15 pm Regulation of Contained Facilities and Greenhouses Dr. Vibha Ahuja
Chief General Manager, Biotech Consortium India Limited and Senior Advisor, South Asia Biosafety Program, India
1:00 pm Lunch and Prayer Break
2:30 pm Regulation and Conduct of Confined Field Trials Dr. Karen Hokanson
Senior Scientific Program Manager, Agriculture & Food Systems Institute, USA
3:15 pm Confined Field Trials Exercise  
3:40 pm Tea Break  
4:00 pm Readouts from Exercises  
4:30 pm Q&A Session All
5:00 pm End of Day 1  

 

Day 2

November 18, 2023 | 9:00 am - 2:00 pm

Time Topic Presenter/Facilitator
9:00 am Recap of Day 1 and Review of Agenda for Day 2 Dr. Rakha Hari Sarker
Technical Sessions
9:15 am Understanding Post Release Monitoring Dr. Andrew F. Roberts
9:45 am Exercise on Monitoring
10:30 am Tea Break  
11:00 am Documenting Decisions and Meeting International Obligations Dr. Vibha Ahuja
12:15 pm Q&A Session  All
12:45 pm Post-Event Survey and Close of Workshop  
1:15 pm Lunch

 

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