Global Variation and Life Cycle Strategies
Strategic planning, roll-out and management of variations and renewals worldwide
- Variations regulated in LATAM, Asia and the GCC
- EU variations system vs US variations system
- Roll-out of major variations
- Life cycle management with affiliates and with local partners
- Worldwide (e)Submission
Aims and objectivesThis seminar provides you with a thorough understanding of the challenges of global life cycle management. Three experts explain how to plan and roll out variations globally and how to collaborate with local partners on further life cycle duties.
After having attended the seminar, you will be capable of efficient global life cycle management.
The speakers will provide practical examples on CCDS and CMC variations. However, if you are interested in the content aspect of CMC variations, we would recommend the "Global CMC Requirements "seminar.
Basic knowledge of the EU variations system is a prerequisite for the seminar and can be obtained in further seminars or e-learning programmes by FORUM Institut.
(Registration from 08:30)
10:30 Coffee break
- EU: Type IA, IB and Type II, including practical examples
- US: minor, moderate and major changes
- Time- and cost-efficient variations submission
- Other countries following the EU legislation: Switzerland, etc.
- Submission timetable
- Coordination of global renewals
- Reference to local pharmacopoeias
- United States versus European pharmacopoeia
- Further national pharmacopoeias: China, Russia, etc.
- Roll-out in practice
- Roll-out criteria
- Meeting with authorities: When is it indicated?
15:15 Coffee break
17:00 End of seminar
Director, Global Regulatory Marketed Products Therapeutic Area Head General Medicines - Thyroid and Diabetes Biopharma | Global Regulatory Affairs & Quality
Senior Global Drug Regulatory Affairs Manager
Regulatory Affairs Associate Director
Phone: +49 69 6975-0
Fax: +49 69 6975-2505
- Regional variations expertise in LATAM, Asia and the GCC
- Strategic variations expertise for worldwide roll-outs
- Practical examples of CCDS and CMC variations to improve the learning effect
Do you need regulatory affairs expertise for submissions outside the ICH region? Then this e-learning programme is the fast track to becoming knowledgeable in this field, providing you with the fundamentals of regulatory affairs outside the EU, the US and Japan.
The e-learning programme will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements.
Subsequently, you will be able to assess the data necessary to apply for a marketing authorisation and be knowledgeable about the CPP requirements. In other words, you will have the tools to develop a submission strategy.
The e-learning programme 'Marketing Authorisation Outside the ICH Region' comprises three didactic modules that include videos in which the expert Karl-Heinz Loebel shares his expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the three modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Please register for the seminar "Global Variation and Life Cycle Strategies" by clicking '"Register" or "Buchen". You will receive a €100 discount if you also book the e-learning programme (you will be billed €290 + local VAT rather than €390 + local VAT).
This seminar will address peculiarities in developing and submitting an eCTD within the ICH region as well as in worldwide eSubmisssion requirements.
09.05.2019 in München
Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.
08. - 09.04.2019 in Amsterdam