Tech Observer at ISCR 4th Annual Conference

Tech Observer at ISCR 4th Annual Conference

11 - 12 Feb. 2011 ISCR 4th Annual Conference


Tech Observer - the Global CRO attended 4th Annual Indian Society for Clinical Research (ISCR) conference on 11-12 Feb.2011.

Conference Objectives

The objective of the conference was to provide a forum for sharing experiences, for professional advancement of the participants, understanding the policy environment locally & globally and to provide a platform for developing relationships and explore new partnership opportunities.

Conference has 2 tracks – “Clinical Research”, and "CDM, Biostatistics & Medical Writing."

List of few hot topics discussed in both tracks:

Topics / Speakers:

Placebo Use - Pros and Cons : Dr Radhika Bobba Managing Partner, Anhvita BioPharma Consulting

Post Trial Accesses : Challenges and Dilemma -Dr DC Dowal Chief, Department Medical Oncology & Director (Research) Rajiv Gandhi Cancer Institute & Research Centre

Compensation Issues in Clinical Research : Dr Nandini Kumar, Former Deputy Director General ICMR

21 CFR Part 11 : Dr Mandar Oak, Consultant Data Management

Role of regulatory agencies in research in the 21st century : looking beyond approval- Dr Chandrashekhar Potkar, Director Medical & Regulatory Affairs, Pfizer

Challenges of trial conduct for vaccines : Dr Shafi Kolhapure, Director - Medical & Regulatory Affairs, Sanofi Pasteur

Challenge for a CRA : integrating protocol and clinical knowledge in monitoring - Dr Kamala Rai, Director Clinical Operations, Novartis

FDA’s expectations of investigator oversight and source data : Dr Chitra Bargaje, Senior Auditor, BMS

Data Query Rate Reduction : Partnership between Clin Ops and DM - Dr. Chirag Trivedi, Head – Project Management and Strategic Initiatives Sanofi-Aventis

Non-inferiority trial Designs : Current Practices and Issues - Priya Rajagopal, Manager, Biometrics, GSK

Quality in Coding Process : Challenges - Dr. Vikas Gupta, Senior Manager (Pharmacovigilance), Panacea Biotec


Panel Discussion:

Performance and Quality of Indian Sites

Sponsor CRO Relations


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