Aim of Regulatory Affairs Course:

  • Mission to make pharma students and professional, practically strong in Regulatory Affairs field rather than theoretically.
  • To develop knowledge in way that pharma students and other pharma professional can build their carrier in Regulatory Affairs field.
  • Draft a syllabus in such a way that students and pharma professional can easily understand end to end Regulatory Affairs filed i.e. start from product development, authoring of documentation, and registration to various Health Authority and Life-cycle management after product approval / commercialization.
  • To provide knowledge through health authority guidance’s, practical demonstration and case studies.
  • To provide knowledge of all sectors of Regulatory Affairs i.e. Pharmaceuticals, Biopharmaceuticals, API and Clinical industry.
  • To provide knowledge of all the dosage forms i.e. oral solid, parental, sterile, ophthalmic, complex molecules, solution and suspensions
  • To provide knowledge of all the regulated market i.e. US, EU and Canada
  • To assist pharma students and professional life-time with new requirements and guideline updation.
  • To practically understand the basic fundamentals / concept of RA field
  • To conduct timely webinars / workshops / trainings in colleges and pharma industry

Content of Regulatory Affairs Course:

  • Topic 1 – Regulatory Affairs Professions
  • Topic 2 – Structure of Pharma industry and its functioning
  • Topic 3 – Industries i.e. Pharmaceutical, API, Biologic and Medical Device
  • Topic 4 – Product manufacturing process for various dosage form
  • Topic 5 – Clinical Studies and Pharmacovigilance
  • Topic 6 – Intellectual property rights (IPR)
  • Topic 7 – cGMP, GDP and GLP requirements
  • Topic 8 – Generic drug regulatory project planning and management
  • Topic 9 – Generic drug development and approval process
  • Topic 10 – ICH guidelines and related regulatory authority specific guidelines
  • Topic 11 – GMP documents required for generic drug application submission
  • Topic 12 – Dossier submission in pCTD, eCTD and NeeS format
  • Topic 13 – Regulatory requirement and system in US, EU and Canada
  • Topic 14 – Different types of submissions (Pre-approval & Post approval)
  • Topic 15 – Administrative and country specific requirements
  • Topic 16 – Preparation of Labeling for US, EU and Canada
  • Topic 17 – Regulatory and Medical writing

  • Mode of Syllabus and Methodology

    • Class room training / Online training / Distance learning
    • Printed Training Modules and Online e-learning System

  • Who is Eligible for Course

    • In any pharma / science graduates
    • Pharma professional from various department
    • Final year students of M.Pharmacy / B.Pharmacy / D.Pharmacy

  • Duration of Course

    • Class room training (4 months)
    • Online training (6 months)
    • Distance learning (6 months)

  • Examination

    • After completion of every milestone, Online and Offline MCQs and practical examination

  • Certification

    • Certificate would be awarded upon successful completion of the program as “Post Graduate Diploma in Regulatory Affairs” by Masuu Global.

  • Registration

    • Masuu Global will always update the students and pharma students for upcoming new batches through email and other media.

  • Fee Structure

    • Nominal charges for Class Room Training / Online Training / Distance Learning

  • Our Team Expertise

    • All experienced and qualified pharma professional from different department of pharma industry

  • Guaranteed Placement Assistance

    • Masuu collaborated and connected with multiple pharma companies for job assistance to all registered students and pharma professionals.
    • Team Masuu is updating job database on daily basis for available jobs and will inform to candidate through mails regarding jobs availability across the India along with proper interview guidance

  • Apply Now

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