Clinnovo Research Labs offers high quality training in Clinical Research, CDM, Regulatory affairs and Pharmacovigilance with strong emphasis on practical training and projects.
Pharma Regulatory Affairs, a new specialized profession has developed from the requirement of regulatory authorities to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The Regulatory Affairs professional's job is to keep track of the ever-changing legislation in all the regions in which bio pharmaceutical company wishes to distribute its products. These professional also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data captured by their research and development team.
In Clinnovo the training is mainly emphasised on strategic and technical development of an individual, acquiring knowledge in Regulatory affairs right from the beginning.
1. Basics of Clinical Research
2. Importance of Ethics in Clinical Research
3. ICH GCP
4. Understanding essential documents and their requirements in Clinical Trials
5. Overview of the Emerging Indian Regulatory Scenario: Schedule Y
6. Indian GCP
7. ICMR Guidelines
8. USFDA regulations
9. Introduction to Regulatory Affairs Services (Reviewing, Compiling and Submissions of Documents)
10. Essentials of Informed Consent Documents: Developing and Reviewing ICFs
11. Essentials of Protocol Development
12. Essential Concepts on IEC: Understanding the Review Process
13. Understanding the process of various submissions
BA/BE submission Vs. Clinical Trial submission
