Certificate Program in Regulations for Biologics and Pharmaceutical Product [6Months

]
Aims and Objectives
These unique courses are formulated to deepen your understanding of current regulations and their practical applications in the development of & commercialization of drugs ,biologics and medical device products. To gain the essential knowledge and skills required to help companies for regulatory environment. Acquire the foundation to work within or in variety of areas including medical products development, pharmaceutical formulations, sales, strategic marketing and clinical investigations.

What Will You Learn?
Gain advanced tools necessary to optimize and maintain your regulatory procedures Obtain the knowledge necessary to keep up to date with new legislation in a constantly changing environment Facilitate improvement in your review and maintenance procedures Improve your day to day management of regulatory affairs

Learning Outcome:
Understand Regulatory Concepts Able to write and review Regulatory Documents Marketing Authorization from different countries

Indian Biosciences and Research Institute, Noida

Page 1

The pharmaceutical industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. quality assurance. pharmacovigilance and others are considered regulatory professionals.Course Content S. drug safety. Modules 1 Module I 2 Module II 3 4 Module III Module IV Content Introduction to Regulatory Affairs and Profession International Licensing and Drug Regulatory Affairs Regulatory Documentation for Biologics /Medical Diagnostics And Pharmaceutics (Submission of DMF. It opens up lot of opportunities as it covers a variety of disciplines. Noida Page 2 . Dossiers etc.) Research study Career Opportunities A career in Regulatory Affairs is both a challenging and highly rewarding career. clinical trials. compliance. Type of companies hiring RA professionals: o Pharmaceutical o Medical Devices o In Vitro Diagnostics o Biologics and Biotechnology o Veterinary Products o Cosmetics o Local FDA/ US FDA/UK MHRA/EDQM o Ministry of Health/DCGI o Clinical Research Organization/ Contract Research Organization o Pharmaceutical consultancy companies RA professional can get employment as: o Regulatory Affairs Associates o Regulatory Affairs Assistance Indian Biosciences and Research Institute.No. Individuals who are directly involved in regulatory submission.

Successful students will be awarded ‘Certificates in the respective areas by Distance participation along with the grade obtained. Course Methodology After the Enrollment the student will be provided study material in form of books. Dossier etc. Indian Biosciences and Research Institute.o Regulatory Affairs head/ Director o Medical Information Associates o Drug Inspector/Drug Controller/ o Drug Safety Specialist/ Regulatory Food Safety Scientist o Quality Operations/Quality Control/Quality Assurance o Regulatory Affairs Consultants Characteristic Feature of the course is that for the six months and one year course the candidate has to submit one case study related to DMF /E-CTD. Evaluation will be examination/assignment based. Noida Page 3 . power points i. Introduction Kit is delivered to participants of the program – this kit will contain study material and all necessary information about the program with important dates.e.

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