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Berlin, DE
Boost Your eRegulatory Strategy With Leading Advice And Success Strategies For RIM, IDMP, Global eSubmissions and Filing Variations
Regulatory Authority insights and industry case studies exploring SPOR, IDMP, CESSP, eCTD 4.0.
Overcome Your eRegulatory Hurdles
Across two tracks designed to help you take your RIM & IDMP and eSubmissions processes to the next level, and a full day workshop designated to filing variations best practice, you will discover how to implement a robust eRegulatory strategy.
Regulatory Information Management
RIM & IDMP: It's time to harness the true value of your data.
Global eSubmissions
Refine your global eSubmissions approach for faster and more efficient dossier approval.
Workshop: Filing Variations
Get speedy regulatory approval and ensure your filing variation procedures are cost-effective.
Run by Global Pharmaceutical Regulatory Affairs Summit's official training division.
Develop your eRegulatory knowledge with Regulatory Authorities and industry leaders
Get a glance of some of the RIM, IDMP, eSubmission and filing variation talks you won't want to miss out on below...
SPOR | An update on the implementation guides: Scope, requirements and advice for industry
- Walking through the implementation guides step by step
- Assessing how the implementation guides are being interpreted
- Industry feedback on the draft implementation guides
- An update from the task force on expected time-lines Lack of available guidance for iteration one
Patrick Middag, Associate Director, Regulatory IT, Bristol-Myers Squibb
eCTD v4.0: Timelines, scope and industry feedback
- Assessing the status of eCTD v4.0
- Examining the time-lines for implementation
- Assessing feedback from ICH and industry
Bernd Misselwitz, Director, Regional Head of Regulatory Submission, Bayer
ISO IDMP related implementation at and by the regulator - MEB experience and views on substance management
- Progress on the implementation of IDMP substance management through EU-SRS
- Views of a National Competent Authority on the role of data in regulatory exchange
- Relation of standards to the telematics plan of the MEB
- Discussing the status of SMS implementation in the EU
Joris Jampmeiher, CIO, Medicines Evaluation Board
An update on eSubmissions in China
- Providing clarification on the move to the eCTD
- Assessing available guidance for eSubmissions in China
- Practical advice for submitting to China
- Examining the common pitfalls and understanding how to overcome them
Dai Wan, Regulatory Project Manager, Merck
HEALTH AUTHORITY AND INDUSTRY PANEL DISCUSSION | Global eSubmissions regulatory landscape: Preparing for the future
- Assessing the strategic roadmaps for electronic submissions
- Assessing opportunities for alignment and harmonisation amongst Health Authorities to improve submissions globally
- Examining common pitfalls during eSubmissions processes and how they can be avoided
- Advice for industry when planning a global eSubmissions strategy
Alastair Nixon, Director, Submission Standards, Global Regulatory Platform & Delivery, GlaxoSmithKline Research & Development Ltd
Massimiliano Sarra, Preclinical & Clinical Assessor, AIFA Agenzia Italiana del Farmaco
Tim Powell, Associate Director, Global Regulatory Operations, Biogen
Workshop: Filing Variations
- Get speedy regulatory approval and ensure your filing variation procedures are cost-effective
Sumaiya Patel, Director, Independent Consultancy
RIM, eSubmissions & Filing Variations: Meet Our Speakers
Join leading experts in the field to discover best practices for your eRegulatory strategy.
