Academy for Clinical Excellence, Mumbai

How can I get details of the Academy for Clinical Excellence, Mumbai diploma in clinical research program???

[Saksham]

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

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