The Institute of Bioinformatics at the University of Pune is organizing an International Workshop on Clinical Research & Clinical Data Management from 8th to 10th July 2004. The workshop has a special focus on vaccine trials and clinical trials of drugs for infectious diseases. The Workshop may also have a slot for a showcase of PhOSCo Clinical Trials.
The clinical data management workshop, a joint initiative by the university, Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT), is intended to become a sustainable quarterly initiative thereby helping the institute to develop as a centre of excellence for training as per ICH GCP guidelines.
The key topics to be covered in the conference are Procedure of Code of Ethics as per GCP guidelines, SOPs: Keys to compliance and Successful Clinical Trial Operation, CRF Designing: A user-friendly Approach, New Challenges to IRBs, Sponsors, and Investigators, Update on the New European Clinical Trial Legislation, FDA Enforcement: What we Need to Know to Respond to the FDA, Pharmacokinetics and Pharmacodynamics, Providing a context for CDM, The influence of Clinical Informatics on Drug Development, The optimized CDM process-Data Mining, Data Flow Modeling, Data Warehousing, and Knowledge Management, An overview of the 21 CFR 11 Regulations and Guidance, Guidance Compliant eCTDs and Data Managers- The Expanding SkillSets.
The expert speakers include Dr. Vasantha Muthuswamy, ICMR, Dr B Swindley, MDS Rostrum, UK, Dr J Jones, Kendle International, UK, Dr S Beeby, Kendle International, UK, Dr M Calder, Phosco, UK, Dr J Lyold-Parks, Technomark, UK, Dr R Kuchibatla, Targacept, USA, Dr GopalaKrishna, Guilford Pharmaceuticals Inc, USA, S Ramu, Quintiles, India, F. Newby, CDISC, USA and B. Regal, Apothecaries, India.