-----------To download Application Form Click Here -----------
Program Objectives
To be the biggest knowledge enhancement movement in the world in
the area of Pharma Regulatory Affairs.
- To spread, enhance and share knowledge in the emerging areas of
Pharma Regulatory Affairs.
- To provide quality inputs in the area of Pharma Regulatory
Affairs, to working professionals and individuals who have completed their
education and willing to contribute in this area.
- To develop documentation / research writing expertise in the
Pharma Regulatory Affairs area.
- To equip participants of the BII Industry Program in Pharma
Regulatory Affairs to be able to spread awareness in this area by sharing
their knowledge with others.
- To be a platform for interchange and exchange of knowledge in this
area by organizing interaction with Companies and program members.
- To make available a pool of competent professionals in the area
of Pharma Regulatory Affairs.
Program Methodology
- Prospective Participants join the program by submitting
participation form with necessary participation fee.
- Delivery of Program Kits and Participation material to the
participant.
- The participant will go through the program kit and participation
material by himself and through BII's centralized support.
- The participant with support of BII and his own initiative will
participate in the program by:
- Self Study of Program Kit and other issued material
- Time Bound Preparation of a Research Report on the allocated topic
through BII and his own resources (e.g employer, academic institution,
library, internet etc). Submission of Research Report to BII .
- Time Bound Completion and Submission self analysis work books to
BII .
- Interacting with other participating members and organizations through BII Blog at http://www.biinoida.blogspot.com
- Spreading awareness about Pharma Regulatory Affairs area with
others through knowledge sharing.
- Time Bound Completion of the Program
- Receiving Citation & Experience Certificate from BII about objectives achieved during the program.
Program Areas
Clinical Trial Team.
Clinical Trial Delivery Model.
Clinical Trial Business Environment.
Clinical Trial Regulatory Affairs.
Bioethics.
Audit of Clinical Trials.
These modules cover important concepts like:
Pharmaceutical Administration and Management, Handling laboratory and
manufacturing deviations, Pre approval inspections, Impact of Total Quality
performance, GMP Certification and enforcement actions, Maintenance and
Update of Product Master Files , Internal Compliance of Documentation,
Coordination and Assembling of CTD/eCTD, Quality systems, Quality Assurance,
Method Validations, Process Validations, Master Validation Plan, Protocols,
Standard Operating Procedures (SOPs), Auditing and Compliance Functions,
Regulatory strategies, Regulatory agencies, legislation and documentation
systems as required for USFDA, UKMCA/UKMHRA, MCC, WHO etc. , FDA/UKMHRA
Queries and submission , Application requirements and guidelines ,
Electronic submissions , Medical device regulations , Stability as per ICH
,guidelines & MBRs; International harmonization , Practice of regulatory
affairs, USP, Pharmacological, Toxicological and Clinical Trial Information,
Re-registration Documents Design, Role of the International Business
Operations of the Pharmaceutical MNCs in Attracting the FDI, Clinical
Pharmacy, Drug Trials and Vaccine Trials Guidelines, Drug Laws , What is
IND? , Formatting, assembling and submitting the NDA, Human Genetic
Research, Clinical Trials, Indian Ethics Committee, Good Clinical Practices
(GCP), Pharmaco-vigilance and ADR reporting , Clinical Trial Regulation,
Intellectual Property Rights, Basis of Patentability, Patent Application
Procedure, Compulsory License, Infringement of Patents, Product Registration
for Regulated and Non Regulated Markets etc.
Deliverables
Program Deliverables include:
Training Kits comprising of Reference Materials and Free Lecture CDs, Support via Internet, Email and Telephone and Information exchange via BII Blog.
How To Join
In order to join BII Industry Program on Pharma Regulatory Affairs the prospective participant has to submit the necessary form. Down Load Now
BII Blog
BII Blog - is an open interactive knowledge platform
for you. It is meant to be a platform "Of the Participants, for the
Participants by BII". BII Blog will provide the following facilities:
- Knowledge interchange and exchange among the users.
- Web based resources.
- Information sharing on jobs, events etc.
- Other activities of mutual interest among the users.
So, through this Synchronous Discussions - computer mediated communication
(CMC) participants are able to communicate with other participants of the Institute
to share news, views, comments and opportunities in the domain area.
BII Blog is available on
website. The link is http://www.biinoida.blogspot.com. All program participants are provided access to BII Blog.
Eligibility
The eligibilty for the training program is graduation in any discipline.Highly interested participants in final year can also apply.
Program Fee
BII Program Participation Fee for this program is Rs 10000 (for participants based in India / USD 750 ( for overseas participants ). Payment is to be made through Demand Draft / Telegraphic Transfer in favor of Bioinformatics Institute of India
Examination Fees
Every student has to pay Rs.300/- per module as examination fees . Examination fee for overseas participants is USD 25 Per Module
Program Duration
The program duration is 12 months.
Evaluation
At the end of the duration of a program, participants go through a well defined evaluation process which is held on all India basis.
Program in Pharma Regulatory Affairs Industry and Career Prospects
A career in Regulatory Affairs , unfolds a vista full of opportunities .Since the early 1960's, there has been an ever-increasing public and government interest in the safety and efficacy of pharmaceutical and medical device products. This interest has been accompanied by a growing number of regulations that regulatory agencies, such as the Food and Drug Administration, DCI, UKMCA/UKMHRA, have imposed upon the health care product industries.This increase in regulatory requirements for pharmaceutical and medical device products has dictated that companies in these industries establish a distinct department, staffed with uniquely qualified professionals to assure that all these requirements are met.
Types of Companies hiring Regulatory Affairs Professionals
The job opportunities for Regulatory Affairs Professionals are excellent in the areas of Regulatory Affairs and Quality Operations. Career options include the pharmaceutical, biotechnological, veterinary, cosmetic , food and medical devices industries, Contract Research Organizations, government. These professionals will find employment as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates , Drug Inspectors, Drug Controllers, Regulatory Affairs Consultants for Pharma/Biotechnology Industry, Regulatory Food Safety Scientist , Pharmaco-vigilance Manager , Drug Safety Specialist , etc.
Responsibilities when working in Regulatory Affairs
In industry, Regulatory Professionals interact with all departments of the company and based on this cooperation prepare a variety of documents necessary for research, development and production of drugs/medical devices. Frequent interaction with government is necessary to obtain regulatory approval for conducting clinical studies and for production of therapeutics.Regulatory Affairs Professionals, when working for government, assure that industry complies with regulations. Specifically, the Regulatory Professional reviews documents submitted by industry and releases permission for conducting clinical studies or for product manufacturing and distribution, based on regulatory and scientific merits.
Some of our students are associated with the following renowned companies
| Company Name |
Company Name |
| Panacea Biotech Ltd |
Elder Pharma Ltd |
| Spic Science Foundation |
Sai Mirra Pharma |
| Aventis Pasteur India P. Ltd. |
Glaxosmithkline |
| ANZ Grindlays, ABN Amro, Rabo India |
Macleods Pharmaceuticals Ltd. |
| Lupin Ltd. |
Tata Elxsi Ltd. |
| Charak Pharmaceuticals |
A.I.I.M.S. |
| Datatech Information Study Centre |
Tamil Nadu Veterinary University |
| Bio-Rad Laboratories (I) Pvt. Ltd. |
CMC Ltd. |
| NIIT-GIS Ltd. |
Ranbaxy Lab Ltd. |
| Aurobindo Pharma Ltd. |
Stedman Pharmaceuticals (P)Ltd. |
| Dr. Reddy's Lab |
International Institute Of Biotechnology & Toxicology |
| Cadila Pharmaceuticals Ltd. |
Pfizer Ltd |
| GSK India |
Shasun Chemicals&Drugs Ltd. |
| L&T Information Tech. Ltd. / Polaris Software Lab Ltd. |
Infosys Technologies Ltd. |
| Wipro Technologies |
IPCA Lab |
| ANR Right Gen Technology |
Deptt. Of Plant Molecular Biology Univ. Of Delhi |
| Novartis India Ltd. |
N.B.F.G.R. |
| National Informatics Centre (Govt. Of India) |
Netaji Subash Institute Of Tech (N.S.I.T.) |
| IICB |
Fippat |
| Ecosolar Systems (I) Ltd. |
M.E.I. Polytechnic |
| National Institute Of Oceanography |
Nagpur Test Tube Baby Centre |
| Coffee Board-Biotech Centre |
-----------To download Application Form Click Here-----------
For further details and enquiries
| India
| Overseas |
Program Co-ordinator
Industry Program in Pharma Regulatory Affairs
Bioinformatics Institute of India
C-56 A/28, Sector - 62
Noida - 201301, UP(INDIA)
Tel : 0120 - 4320801/02
Mob : 09810535368
|
Dr. Kumud Sarin
INTERNATIONAL ACADEMIC COUNSELLOR
+91-9811420055 |
| E-mail : info@bii.in
| Email: global@bii.in |
