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Fifth Workshop of the IBO Training Program

    October 15, 2022-October 16, 2022
    9:30 am - 5:30 pm
    BCDM Rajendrapur
    Gazipur, Bangladesh

The Agriculture & Food Systems Institute (AFSI), in partnership with the Ministry of Agriculture, Government of Bangladesh, under the auspices of the South Asia Biosafety Program (SABP), is conducting a series of workshops targeting Institutional Biosafety Officers (IBOs) and Committees (IBCs) at research institutions engaged in biotechnology research and development in Bangladesh. The purpose of this by-invitation-only workshop series is to ensure that institutions in Bangladesh are aware of their obligations under the biosafety regulatory system and are empowered to work with researchers to meet these obligations while continuing their research.

The introductory workshop was held on December 2, 2021. The discussion on biosafety compliance while working with genetically engineered organisms continued during the second workshop, which was held virtually on February 17, 2022. The third workshop focused on capacity building exercises for IBOs and IBCs, covering additional topics, including the development of standard operating procedures for greenhouse work, key considerations for containment of GE crops, and key components for record keeping, handling, storage, transfer, shipment, and disposal of GM plant material. Compliance for import, exchange, and research involving GM crops was also discussed.

The fourth workshop in this series, held on June 8-9, 2022, focused on all aspects of confined field trials (CFTs). The topics discussed included the planning of a CFT, key considerations while conducting a CFT, requirements for risk assessment and risk management in the context of CFTs for GE plants, and understanding the requirements and application process for conducting a CFT in Bangladesh. The standard operating procedures for the conduct of a CFT, including handling material, maintaining isolation, harvest and termination, and documentation, which have been approved by the National Biosafety Committee in Bangladesh, were also discussed in detail. An information session on the preparation of crop-specific SOPs, recording formats, compliance with regulatory requirements for a CFT, and monitoring and inspection of field trial sites by regulatory authorities was also included.

The fifth training session in this series was dedicated to understanding regulatory submissions, writing meaningful dossiers, and the process of submission to regulatory authorities. IBOs gained a better understanding of the context of regulatory submissions and the difference between the type of data included in a dossier for regulatory submission and data included for reporting results of a research project. This training session covered the data requirements for both food safety assessment and environmental risk assessment in detail. Presentations were delivered on best practices in regulatory dossier development, and this will help the IBOs to support product developers in preparing their dossiers for submission.

Speakers

Rakha Hari Sarker, Ph.D.
Country Coordinator South Asia Biosafety Program (SABP)
Andrew Roberts, Ph.D.
Chief Executive Officer Agriculture & Food Systems Institute (AFSI)
Aparna Islam, Ph.D.
Professor Brac University
Vibha Ahuja, Ph.D.
Senior Advisor South Asia Biosafety Program (SABP)
Bhavneet Bajaj, Ph.D., PMP
Manager, Scientific Programs Agriculture & Food Systems Institute (AFSI)
Sium Ahmed
Biosafety Officer South Asia Biosafety Program (SABP)
Flerida Carino, Ph.D.
Consultant Bureau of Plant Industry, Department of Agriculture and Philippine Food and Drugs Administration
Md. Abdul Kader, Ph.D.
Principal Scientific Officer Plant Breeding Division, Bangladesh Rice Research Institute (BRRI)
Md. Kamrul Islam, Ph.D.
Senior Scientific Officer Cotton Development Board

Agenda

Day 1 - October 15, 2022

9:30 am

Registration

Inaugural Session

10:00 am

Welcome and Introductions

Dr. Rakha Hari Sarker, Country Coordinator, South Asia Biosafety Program (SABP) and Professor, Dhaka University, Bangladesh

10:20 am

Recap of the IBO Training Program

Dr. Andrew Roberts, Chief Executive Officer, Agriculture & Food Systems Institute (AFSI), USA

10:30 am

Regulatory Testing vs. Research Experiments: Why the Data for Your Dossier Is Different From Your Thesis

Dr. Aparna Islam, Professor, Brac University, Bangladesh

10:45 am

Inaugural Address by Chief Guest

Prof. Dr. Lutful Hassan, Vice-Chancellor, Bangladesh Agricultural University,
Mymensingh

11:00 am

Vote of Thanks

Dr. Vibha Ahuja, Senior Advisor, SABP and Chief General Manager, Biotech Consortium India Ltd. (BCIL), India

11:05 am

Tea Break

Technical Session 1

11:30 am

Regulatory Submissions: Context and Key Considerations

Dr. Vibha Ahuja, Senior Advisor, SABP and Chief General Manager, BCIL, India

12:00 pm

Molecular Characterization: Data Requirements

Dr. Flerida Carino, Consultant, Bureau of Plant Industry, Department of Agriculture and Philippine Food and Drugs Administration, The Philippines

12:30 pm

Data Needs for Safety Assessment of Foods Derived from GE Plants

Dr. Bhavneet Bajaj, Manager – Scientific Programs, AFSI, USA

1:00 pm

Lunch

Technical Session II

2:15 pm

Data Needs for the Environmental Risk Assessment of GE Plants

Dr. Andrew Roberts, Chief Executive Officer, AFSI, USA

2:45 pm

Group Exercise: Relevance of Data Requirements

Mr. Sium Ahmed, Biosafety Officer, SABP, Bangladesh

3:30 pm

Tea

3:45 pm

Regulatory Submissions: How to Make Use of Resources and Existing Information

Dr. Rakha Hari Sarker, Country Coordinator, SABP and Professor, University of Dhaka, Bangladesh

4:15 pm

Experience Sharing

Dr. Md. Abdul Kader, Principal Scientific Officer, Plant Breeding Division
Bangladesh Rice Research Institute (BRRI)

4:45 pm

Experience Sharing

Dr. Md. Kamrul Islam, Senior Scientific Officer, Cotton Development Board

5:15 pm

Q&A Session

5:30 pm

Close of Day 1

Day 2 - October 16, 2022

9:00 am

Recap of Day 1

Dr. Bhavneet Bajaj, Manager – Scientific Programs, AFSI, USA

Technical Session III

9:15 am

Product Developer Expectations and Needs from the Regulatory System

Dr. Andrew Roberts, Chief Executive Officer, AFSI, USA

10:00 am

Interpreting Regulatory Requirements: Knowing When Data Are Not Necessary

Dr. Flerida Carino, Consultant, Bureau of Plant Industry, Department of Agriculture and Philippine Food and Drugs Administration, The Philippines

10:45 am

Tea Break

11:15 am

Best Practices in Regulatory Dossier Development

Dr. Vibha Ahuja, Senior Advisor, SABP and Chief General Manager, BCIL, India

12:00 pm

Q&A Session and Survey

12:30 pm

Lunch & Close of the Workshop