WHO Regional Regulators Meeting in Asia, 2007

The WHO regulatory regional meeting was held in New Delhi, India in the month of October to engage and update stakeholders on regulatory concerns and issues around microbicides. The meeting was well attended by a range of stakeholders,researchers, scientists and microbicides advocates.

Presentations:

Emerging approaches to community involvement in microbicides trials
Presented by Paramita Kundu, Global Campaign for Microbicides in india

Treatment Access in Trials and Beyond
Presented by Gita Ramjee, HIV Prevention Research Unit

Regulatory Considerations in the Development of Topical Microbicides
Presented by Prof. S. D. Seth, Advisor Indian Council of Medical Research

Vaginal Rings and Microbicides
Presented by Mark Mitchnick, MD, International Partnership for Microbicides

Microbicides Applicator: Overview and Regulatory Issues
Presented by Maggie Kilbourne-Brook, PATH

Non-clinical evaluation of Microbicides: Scientific Approaches
Presented by: Alan Stone, London, UK

Measuring Adherence in Microbicide Trials
Presented by Robert Pool, Microbicide Development Programme

Effectiveness: Overview of Current Approaches and Emerging Trial Designs
Presented by Doug Taylor, PhD, Director of Biostatistics, Family Health International

Microbicide Trials - Role of Data and Safety Monitoring Boards
Presented by Tim Farley, Department of Reproductive Health and Research, WHO, Geneva

Regulatory Challenges
Presented by Peter Karlton

Regulatory Issues in China
Presented by Li Yajie, SFDA-CDE

Microbicide Acceptability: Overview of Methods & Findings
Presented by Seema Sahay, Ph.D, Assistant Director, National AIDS Research Institute

Community Involvement in Clinical Trials
Presented by Dr. Sunita Chaudhari, Cab Member, National AIDS Research Institute

Assessment of Safety of Microbicides
Presented by Dr Smita Joshi, Senior Research Officer, National AIDS Research Institute

Role of MCC/MRAIN Approval of Clinical Trails and Final Market Authorisation of Microbicides
Presented by: Dr R N Misra, Director of Clinical Evaluations & Trials Directorate, National Department of Health

Microbicide Products in the Pipeline
Presented by Dr. Zeda F. Rosenberg

Delivering Microbicide: Challenges and Opportunities
Presented by Sanjay Garg, School of Pharmacy, University of Auckland

Microbicides in the context of prevention technologies
Presented by Prof. Helen Rees, Reproductive Health -HIV Research Unit, University of Witwatersrand

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