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Regulatory Affairs Strategy Training Course

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Where: TonyResort, Anupriskiu k. 2, Trakai district, Lithuania

This 1-day course will provide you with clear understanding of European regulatory requirements throughout all product lifecycle and it will demonstrate the strategy of effective management of regulatory affairs process. The training is based on variety of key topics including regulatory legislation, submissions, labelling, strategy, compliance during pre and post marketing phases. The course will expand your knowledge and develop the interpretive and analytical skills required for effective and strategic management of regulatory affairs.

Learning Objectives

After completing this training participants shall:

  • Gain and consolidate the information required to stay current with European regulations

  • Acquire a comprehensive understanding about CTD and eCTD

  • Learn the key elements of successful regulatory affairs strategies and how to apply them in practice

  • Bring medicinal products to market faster, better, and smarter

Who Should Attend

This course is relevant for anyone working within the fields of:

  • Regulatory Affairs
  • Pharmaceutical Development
  • Clinical and Preclinical Development
  • Manufacturing
  • Quality Assurance

Trainer

ANDREW WILLIS
Andrew Willis is a regulatory expert with 32 years of experience in pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in coordinating, planning and running global development projects. Andrew has been involved in registration of orphan medicinal product, centralized approval for NCE, oversight of CHMP appeal and CMC lead for vaccine and biosimilar projects. He also provides various training courses of advanced regulatory affairs, preparing and writing the common technical dossier, regulatory affairs strategy, variation management programs in global conferences and for all major companies. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment. His experience is wide ranging, and will facilitate your understanding of fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.

Course Agenda

08:00Registration
08:30Welcome and Introductions
09:00What are Regulatory Affairs – General Introduction to RA and Function
What’s New in Regulatory Affairs?
   · Understanding the Impact of New Regulatory Affairs for New Products
   · Interpretation of New Guidelines
   · What is the Impact of New Regulation on Globalization
   · Developing a Compliance Strategy for the New Regulatory Affairs
10:30Coffee break
11:00Management of all European Procedures
Key Factors Influencing Strategy:
   · Procures Types
   · Application Types
   · Outcomes
   · Influencers
12:30Lunch
13:30Understanding Regulatory Intelligence
Regulatory Strategy – What Influences Strategy
15:00Coffee break
15:30Review Procedure for CTD and eCTD
   · Review of CTD for Global Regulations
   · Summary of Modules 3
   · Module ObD and Pharmaceutical Equation
   · Introducing ICH Q12
   · ICH Q3D Impact
· An Efficient Transfer of Regulatory Information
16:30Recapitulation and interactive discussion
17:00End

Price

List Price:     €800 per participant

Training handouts, lunch, coffee and snacks are included.

Group discounts apply for several participants delegated from the same company. Please contact us for more information.

Course Registration

Please complete and submit the training registration form below and we will get back to you within 24h with registration confirmation and details.

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