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15th EGA REGULATORY AND SCIENTIFIC AFFAIRS CONFERENCE London
28-29 JANUARY 2016
Radisson Blu Portman Hotel

2016 PROGRAMME

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Join this unique event! Come to the 15th EGA Regulatory and Scientific Affairs Conference to get an update on recent regulatory developments. Learn from the best and meet the best! Be a part of intense discussions on hot topics affecting the generic medicines industry with nearly 200 participants from the competent authorities and well-known industry experts. Last year almost 60 representatives from the competent authorities attended the EGA regulatory conference. (here the list of companies and organisations present in 2015) Don’t miss this opportunity in 2016!

  • Looking to the future- EMA/HMA Strategy 2020 Work Plan- how will it impact the regulatory environment for pharmaceuticals?
  • Tackling effects of the globalisation of pharmaceutical operations – challenges, opportunities and priorities
  • Maintenance of medicinal products: is there a better way of handling it in practice?
  • Watch this space and be ready to implement:
     Falsified Medicines Directive- regulatory consequences of the implementation of safety features
     EMA policy on publication of clinical data and transparency requirements of the Clinical Trial Regulation
     Borderline medicinal products- Do on-going changes to medical devices, food supplement legislations impact my products?
     How does the ICH 3QD guideline on elemental impurities affect my products?
  • TRACK I: The regulatory implications of developments in the legal and operational environment - impact on supply chain
     API information in the regulatory dossier – Finding the right balance to allow compliance, transparency and operability
     Risk-Based Approaches – Towards more EU convergence in the implementation of the concept
  • TRACK II: The latest developments in the electronic submission environment
     ISO IDMP is around the corner: are we set and ready to start with implementation?
     Road map on eCTD- how to handle the conversion from NeeS to eCTD
  • SPECIAL SESSION: Put your questions to the Regulators. An opportunity to address questions to European Regulators on various regulatory issues

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LIST OF COMPANIES AND ORGANISATIONS PRESENT IN 2015 EVENT FLYER REGISTER FOR BOTH THE 9th EGA PHARMACOVIGILANCE CONFERENCE AND THE 15th EGA REGULATORY AND SCIENTIFIC AFFAIRS CONFERENCE AND GET A 10% DISCOUNT

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CONTACT

Lucia Romagnoli W: www.egaevents.org