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Ankara, TR · Germantown, MD, US — Pharma · Medical · Cosmetic · Food supplement

PharmExpert: Regulatory Affairs in Depth and Regulatory Affairs Management

Dates

Past dates: 17–22 September 2024

Format

Online

Course Objectives

The course provides an overview of regulatory affairs and legislation, regulatory authorities and their decision-making approaches, the development of marketing authorization strategies, preparation of Modules 1–5, reliance-based marketing authorization applications as part of WHO alignment, extension applications and how they differ from variation applications, e-CTD, and application submission and follow-up. It also covers the qualities of regulatory affairs managers, leadership and coaching concepts, communication, planning and time management. The course is intended for regulatory affairs professionals and others working in the pharmaceutical industry who wish to develop a thorough understanding of pharmaceutical marketing authorization. Case-based practical examples will be provided.

Who Can Attend

  • Pharmacists
  • Biology and chemistry graduates
  • Pharmacy students (4th and 5th year)
  • Chemistry and biology students (4th year)

Course Content

  • Introduction to regulatory affairs and legislation, regulatory authorities and their decision-making approaches
  • Developing pharmaceutical marketing authorization strategies
  • Preparing Modules 1–5
  • Reliance-based marketing authorization applications as part of WHO alignment
  • Extension applications and how they differ from variation applications
  • e-CTD, application submission and follow-up
  • Qualities of regulatory affairs managers
  • Leadership and coaching concepts, communication, planning and time management
  • Case-based practical examples

Duration and Capacity

Duration: 15 hours

Training will take place on Tuesdays and Thursdays from 20:00–22:00 and on Saturdays and Sundays from 10:00–16:30. Sessions will be recorded, and participants will be able to watch them again for one month.

Capacity: 40 participants

Course Coordinator

  • Prof. Dr. Belma Koçer Gümüşel
  • Prof. Dr. Bülent Gümüşel
  • Pharmacist Dicle Balbay

Instructors

  • Pharmacist Dicle Balbay
  • Buket Önalan
  • Raban Karasu
  • Elif Aydıner
  • Seher Aslıhan Deniz
  • Ahmet Can
  • Prof. Dr. Bülent Gümüşel
  • Prof. Dr. Belma Gümüşel

Fee

Recorded course

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Terms

The training fee includes VAT.

Discounts are available for group registrations.

An examination will be held at the end of the course, and a Certificate of Attendance will be issued.

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Lesson Videos

Available for 1 month, only to the member who purchased this program.

  • Lesson 1 Regulatory Affairs in Depth and Regulatory Affairs Management
  • Lesson 2 Regulatory Affairs in Depth and Regulatory Affairs Management
  • Lesson 3 Regulatory Affairs in Depth and Regulatory Affairs Management
  • Lesson 4 Regulatory Affairs in Depth and Regulatory Affairs Management – Developing Marketing Authorization Strategies
  • Lesson 5 Regulatory Affairs in Depth and Regulatory Affairs Management – Module 1
  • Lesson 6 Regulatory Affairs in Depth and Regulatory Affairs Management – Module 3
  • Lesson 7 Regulatory Affairs in Depth and Regulatory Affairs Management – Key Considerations for Module 3
  • Lesson 8 Regulatory Affairs in Depth and Regulatory Affairs Management – Key Considerations for Module 3
  • Lesson 9 Regulatory Affairs in Depth and Regulatory Affairs Management – Modules 2–4–5
  • Lesson 10 Regulatory Affairs in Depth and Regulatory Affairs Management – Reliance-Based Applications and Differences Between Extensions and Variations
  • Lesson 11-12 Regulatory Affairs in Depth and Regulatory Affairs Management
  • Lesson 13 Regulatory Affairs in Depth and Regulatory Affairs Management
  • Lesson 14 Regulatory Affairs in Depth and Regulatory Affairs Management