| 14th March 2013 11:25 AM | ||
| Saksham | Re: Academy for Clinical Excellence, Mumbai Here are the details of the Academy for Clinical Excellence, Mumbai diploma in clinical research program; Eligibility The candidate should be a Graduate in Life Sciences, Pharmacy and Medicine with 55% Syllabus This is the syllabus of the program: 1. INTRODUCTION TO CLINICAL RESEARCH Definition, Types and Scope of Clinical Research, Good Clinical Practices Drug Development Process Careers in Clinical Research 2. ETHICS IN CLINICAL RESEARCH Ethical Theories and Foundations, Ethics Review Committee and Informed Consent Process, Integrity & Misconduct in Clinical Research Conflicts of Interest 3. REGULATIONS IN CLINICAL RESEARCH Evolution and History of Regulations in Clinical Research, Patents US Regulatory Structure, IND, NDA, ANDA, Post Drug Approval Activities, PMS, FDA Audits and Inspections EURegulatory Affairs, EMEA Organization and Function, INDIAN Regulatory system, Schedule Y- Rules and Regulations 4. CLINICAL RESEARCH METHODOLOGY Designing of Protocol, CRF, e-CRF, IB, ICF, SOP Pharmaco-epidemiology, BA/BE Studies Report writing, Publication 5. CLINICAL RESEARCH MANAGEMENT Preparation of a successful clinical study, Study management, Project management Documentation, Monitoring, Audits and Inspections Pharmacovigilance Training in clinical research Budgeting in clinical research, Supplies and vendor management 6. BIOSTATISTICS AND DATA MANAGEMENT Importance of statistics in clinical research Statistical considerations at the design, analysis and reporting stage. Data management, Data validation, SAE reconciliation, query management Software considerations For further information contact to the address given below: Address Academy for Clinical Excellence Bombay College of Pharmacy, Kalina,Santacruz (E), Mumbai 400 098 Tel: +91 22 26664568 / 26671032 Fax: +91 22 26671032 E-mail 1: cce@aceindia.org E-mail 2: acebcp@eth.net E-mail 3: acebcp@yahoo.com Map | |
| 11th March 2013 09:24 AM | ||
| mohan babuq | Academy for Clinical Excellence, Mumbai How can I get details of the Academy for Clinical Excellence, Mumbai diploma in clinical research program??? | |
