Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Learning Outcome:
Understand Regulatory Concepts Able to write and review Regulatory Documents Marketing Authorization from different countries
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Course Content
S.No. 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, Dossiers etc.) Research study
Career Opportunities
A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals. 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.
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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, Dossier etc.
Course Methodology
After the Enrollment the student will be provided study material in form of books, power points i.e. 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. Evaluation will be examination/assignment based. Successful students will be awarded Certificates in the respective areas by Distance participation along with the grade obtained.
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