In Reply to Parent Post by Ajit Basrur
subbu, are these industry and proficiency programs (6 months and 12 months) like certificate courses ?
Yes, whatever the courses BII offering is a Certificate Courses. The duration of the Industry Program in Pharma Regulatory Affairs- Distance Learning is one year. In order to complete Industry Program in Pharma Regulatory Affairs - Distance Learning Program, candidate has to clear following seven compulsory papers.
Paper 1 - Pharma Regulation, Practices & Procedure
Paper 2 - Pharma Patents, IPR and Regulation
Paper 3 - Pharma Regulatory Regime in USA, EU and India
Paper 4 - Clinical Trials & Regulation
Paper 5 - Good Manufacturing Practices, Quality Assurance and Regulation
Paper 6 - Regulatory Compliance for Pharma and Biotech Products
Paper 7- Research Study
For more details refer attached prospectus.