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Seminar Pharma - Global CMC Requirements covering the Lifecycle
Global CMC
Requirements
Quality data
for non-EU countries
2019-12-21 2020-01-22 Novotel Frankfurt City Lise-Meitner-Str. 2 60486 Frankfurt H1049@accor.com +49 69 79303-0 +49 69 79303-930

Global CMC Requirements covering the Product Lifecycle

Quality data for non-EU and management of company's global CMC interfaces

Global CMC Know-how with focus on Brazil, China, Russia and Japan. After attending the seminar you will have a profound understanding of your CMC duties within the international pharmaceutical environment.
Topics
  • Quality data for marketing authorisation and for post-approval changes with focus Brazil, China, Russia and Japan
  • Assurance of compliance at international level
  • General management of company's global CMC interfaces including a workshop

Aims and objectives

The focus of this seminar is on CMC requirements in non-EU countries. Another key topic is the question on how to continuously secure regulatory compliance along the international interfaces.
Our experts will pass on their in-depth knowledge of standards especially for the Brazilian, Chinese, Russian and Japanes markets. They will share their experience on international variation management and give you an insight into the world of GMP. During the workshop you will have the opportunity to discuss and share your compliance issues and find personal solutions.

After attending the seminar, you will have a profound understanding of your CMC duties within the international pharmaceutical environment covering both: concrete content related topics and managerial interactivities at the interfaces: Thereby improving your skills to work towards the expectations of your interfaces.
Who should attend
This seminar addresses the needs of those working in the international pharmaceutical industry. It will particularly benefit those dealing with international regulatory CMC topics and interfaces, such as

  • CMC managers
  • Regulatory Affairs managers
  • Regional Affairs managers
  • Quality Compliance managers
  • Quality Assurance managers
Speakers
Your speakers
Dr. Christina Juli
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach

Dr. Beatrix Metzner
Boehringer Ingelheim Biopharmaceuticals GmbH, Biberach an der Riss

Dr. Jacqueline Schaller
PharmaLex GmbH, Mannheim

Dr. Mónica Unger-Bady
Unger-Bady Consulting & Services, Berlin


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