Regulatory submission to Europe [Formulations]

To protect public health and ensure the availability of high quality, safe and effective medicines for European citizens, all medicines are authorized before they can be placed on the market in the EU. Manufacturers, importers, and distributors of medicines in the EU must be licensed before they can carry out those activities. The regulatory authorities of each Member State are responsible for granting licenses for such activities taking place within their respective territories.

Category: Crash Courses
Duration : 5 hours 30 minutes

Learning objectives

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Anyone willing to understand this topic can enroll.

Syllabus

  • Section 1: Eu agencies, Marketing authorization procedures, Patents, Submission modules, variation filing

    • Introduction to Eu agencies, Marketing authorization procedures 97 minutes
    • Centralized procedure, National procedure, MRP & DCP 93 minutes
    • Eu Patents 32 minutes
    • Variations 35 minutes
    • Eu Module 1 & Module 2 115 minutes

Fees : 4248

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    Course Include :
  • Video
  • PDF
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