Certificate in Clinical Research and Regulatory Affairs
Clinical Research is a branch of medical science that helps in adjudicating the safety and effectiveness of medications, medical devices, operative procedures, diagnostic products and many more that can help in diagnosing, preventing, managing and curing any pathological or medical conditions. Historical evidences have shown that, if neglected, these animal or human trials can lead to untoward problems ranging from scientific situations or humanitarian catastrophes. These events have led to a series of understandings and acceptance of some critical aspects on which the trials have to be conducted. These aspects are called the Regulations and Guidelines. Some Important Regulations and Guidelines as per the countries, which are very much in use are. For trials conducted in India: Schedule Y, ICMR Guidelines. Some International Regulations: FDA, EMEA directives, ICH-GCP Guidelines, etc. Currently, most of the Pharmaceutical Companies as well as Contract Research Organizations (CROs) have a dedicated unit of Regulatory experts which comprise the regulatory department. The need for such a set up is as follows:
Over the past few years there has been significant changes and development in the Indian medical landscape. There has been a growing demand for regulatory and auditing services in clinical trials and researches. All regulated markets give emphasis on the quality of clinical trial, whether it is prior to the trial, during the trial or after the trial.
For several companies, the failure of any audit might not only be very expensive, but also concerning as in an industry that is the largest globally, the word of mouth becomes very crucial.
Regulatory affairs in itself is a vast area which may include Authoring NDAs, Study design, Regulatory project for submissions/Registration etc.
IICR is providing its students a comprehensive course curriculum which will result in attaining a good amount of expertise in various areas of Regulatory Guidelines along with Clinical Research.
MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.
Mode
- Distance learning / online
Validity up to
- Distance learning / online
Academic Assistance
- 5 hours E-learning with in-house faculty.
Exam Pattern
- E- VIVA and project submission within course validity period.
Placement Assistance
- 2 hours E-session with Placement Department + 3 chances to appear for an interview with in course validity period.
Study Material will be provided.
- Introduction to Clinical Research, Principles of Pharmacology (including toxicology) & Drug Discovery & Development
- Clinical Trail Documents, Roles & Responsibilities of Key Stakeholders
- Project Life cycle: Planning, Study Feasibility, Start-up, Initiation, Trial Monitoring & Closeout essentials, Clinical Trials Design & Budgeting
- General Overview of Pharmacovigilance & Management of Clinical Database.
- Introduction to Regulatory Affairs:
I. Regulatory authority governing clinical trials of New Drugs & Generic Drugs (FDA, EMEA & MHLW), ICH Overview, CIOMS, WHO
II. Regulatory Submissions & Global Regulatory procedure:
– USFDA – IND, NDA & ANDA filing,
– EU – NP, CP, DCP & MRP Procedure,
– MHLW – CTN & NDA,
– TGA – CTN & CTX
– ANVISA
III. Indian Regulatory Environment –
a. Introduction to major regulatory bodies in India – CDSCO, DCGI, DTB,
b. Introduction to D & C Act, Schedule Y, Indian GCP, ICMR,
c. Clinical trial application & Drug approval procedure
IV. Regulation applicable for Pharmaceutical Devices
Note:
(For more details please contact on Mob : 08511188845 or write on ahmedabad@iicrindia.com)
* “Fees (Registration & program fees) once paid will not be refundable”