Biotech and Pharmaceutical companies conduct clinical trials to study the efficacy and safety before releasing the products to the market. This course provides a practical and thorough study of regulations that govern conduct of clinical research, the responsibilities of sponsors, ethic boards, CROs, investigators and monitors during the drug development and approval process. It includes knowledge of setting up and monitoring of clinical trials at investigational sites and documentation inherent to the process. This two days course is designed for training individuals who would like to get involved in regulatory,clinical affairs, clinical operations and clinical trial management. This is an interactive course encouraging participant’s involvement. Students, scientists and professionals are eligible to attend. Enrollment Limited.

Intructor: Nurjehan Jivani, MS, RAC.

Nurjehan Jivani is currently with Symbio, LLC, a CRO, as an Associate Director, Scientific Affairs. She coordinates clinical trails and manages product development, regulatory, due diligence activities. She has extensive experience with different pharmaceutical product areas and phases of the development cycle. Demonstrated global, interdisciplinary project management and team leadership. She is a contributing author to regulatory CMC sections for CTX, CTA,IND and NDA submissions. She has special expertise in new product development from formulation through scale-up and commercialization. Contributed to four successful product approvals like Avita®, Mentax®, Rosanil® and Clobex Spray®. She has Masters Degree in Pharmaceutical Sciences under Dr. Takeru Higuchi, University of Kansas, and M.Pharm from University of Bombay. She has worked at various pharmaceutical companies like Glaxo, Mylan-Bertek Pharmaceuticals, Dow Pharmaceutical Sciences in various capacities.

Topics :

• Introduction to Drug Development Process and History behind the FDA regulation.
• Introduction to Phases of Clinical Trials, Phase I, II, III and IV.
• Regulatory Strategy , Corporate goals, financial impacts on drug development and clinical process
• Introduction to the FDA, ICH, Regulatory Submissions(IND, IDE, and NDA)
• Role and responsibilities of CRA, CRC and CPM
• Overview of Clinical Research and Standard Operating Procedures(SOPs)
• Regulations and Good Clinical Practice(GCP)
• Institutional Review Boards(IRBs) and Informed Consent Forms
• Key elements in Clinical Trial Design,Protocols and Case Report Forms(CRFs)
• Site Selection, Site Initiation, Investigators meeting and Regulatory package
• Clinical Study - Conduct, Monitoring and Closure
• Overview of the important documents needed during Clinical Trials
• Responsibilities of the Investigators, Monitors and the Sponsors in Clinical Trials
• Adverse Events, Safety monitoring and Audits