Certificate in Clinical Research and Bioequivalence and Bioavailability studies
Pharmaceutical companies are now a day immensely competitive and are spending billions of rupees in the new drug development process. On the other hand , most of the companies are in conquest of the generic market also; Generics are not required to repeat the extensive clinical trials used in the development of the original, brand-name drug. Instead, generics must show they are bioequivalent to the pioneer (Innovator product) drug and fall into acceptable parameters for bioavailability, or the extent and rate at which the body absorbs the drug.
In recent times, Bioavailability and Bioequivalence studies is of interest to all in the fraternity of Pharmaceutical and Medical Sciences. India as an emerging hub of such generic studies, it is of paramount importance that the regulatory requirements for the conduct of the bioavailability and bioequivalence studies mentioned in the widely prevailing guidelines of the respective regulatory authorities are understood. In India, currently lots of outsourcing for bioavailability and bioequivalence studies are being carried on.
Clinical Research Organization and Pharmaceutical companies are conducting bioavailability and bioequivalence studies for ANDA submission to regulatory authorities such as FDA (USA), EMEA (Europe), ANVISA (Brazil), CDSCO (India), TGA (Australia) etc. The requirements mentioned in the guidelines for conduct of such studies by these regulatory authorities vary.
IMPERIAL Institute of Clinical Research is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.
The APGDCR-BA.BE course curriculum is fully reviewed and endorsed by the Clinical Research Industry and the academia which enables professionals working in the clinical research industry with the skills and knowledge required being the part of team as there are ample numbers of the professionals required in this arena.
5 hours E-learning with in-house faculty
Exam Pattern:
- E- VIVA and project submission within course validity period.
Study Material:
- Study Material will be provided.
2 hours E-session with Placement Department + 3 chances to appear for an interview with in course validity period.
⦁ Introduction to Clinical Research, Principles of Pharmacology (including toxicology) & Drug Discovery & Development
⦁ Proof of concept studies, Introduction to IPR, Definition of BA BE – need of bioequivalence studies, Types of BA /BE studies, ANDA approval, Bio waivers, BA-BE Trial Design
⦁ Clinical Trial Documents, Roles & Responsibilities of Key Stakeholders
⦁ Process Mapping in BA/BE Studies: Planning, Bio analytical method Development, Start-up, Initiation, Trial Monitoring & Closeout essentials
⦁ Introduction to Regulatory Affairs: I. Role of FDA in governing clinical trials of Generic Drugs – 21 CFR Part 320
II. Role of ICH, CIOMS, WHO
III. Indian Regulatory Environment –
i. Introduction to major regulatory bodies in India – CDSCO, DCGI, DTB
ii. Introduction to D & C Act, Schedule Y, Indian GCP, ICMR,
iii. CDSCO Guidelines for BA-BE studies
IV. Regulation applicable for Pharmaceutical Devices
⦁ Introduction to Quality Management systems. Components of Quality Management System: QMP, QA, QC
II. Tools for QC: SOPs, Operation Manual, Checklists,
III. Tools for QA: Audits & Inspections
⦁ Biostatistics & Overview of Clinical Data Management
Note:
“Fees (Registration & program fees) once paid will not be refundable”
For more details call on 08511188845 or email on ahmedabad@iicrindia.com