Industrial Training
Professional Diploma in Regulatory Affairs

Module I

  • Introduction to Drug & Cosmetic Act with emphasis

    • Schedule M

    • Schedule Y

  • Approval of Drugs

  • Introduction to FSSAI

  • Opportunities in Regulatory Affairs

  • Approval of Food Products & Nutraceuticals

Module II

  • International Regulatory Affairs

  • Introduction to ICH guidelines

    • Module I

    • Module II

    • Module III

    • Module IV

    • Module V

Module III

  • Introduction to Common Technical Document (CTD)  & eCTD

  • Preparation Of Dossiers

  • Import  & Export of Drugs

  • Workshops

Mode: Distance learning

Duration: 4 Months

Methodology:

  • Detailed, Easy to read, Printed material will be provided to enrolled candidates.

  • One Week long Workshop will be held for enrolled candidates to further enhance their skills.

  • Online Guidance & Mentoring available for enrolled candidates

Evaluations:

  • Candidates will be given four assignments to complete and will be evaluated on the basis of assignments only.

Certificate

  • Certificate will be awarded to candidates on successful completion of Program .

Eligibility:

  • B. Pharma, M.Pharma, B.Tech, Graduate/Post Graduate Degree In Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and Hospitals.

Course Fee:

  • Course Fee is Rs 30000+taxes (as applicable)

  • Fee Payable by Cash, Cheque/Bank draft in the name of “Pharma Instinct” payable at Chandigarh.

 Job Assistance :

  • Placement support would be provided to the successful candidates. CVs of successful candidates would be forwarded to relevant organization.