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.

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:

Study Material will be provided at correspondence address

Program Details :

  • 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 systemsI.        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

(* The Date of Joining is the date on which 1st study material will be dispatched to you from institute)

 

[maxbutton id=”2″]

 

(For more details please contact on Mob :08511188845 or write on ahmedabad@iicrindia.com)

*   “Fees (Registration & program fees)  once paid will not be refundable”

 Click here to download Form