EMA Update

You will find in the following two communications from the EMA: the survey on Initial Marketing Authorisation Application as well as an invitation to a multi-stakeholders workshop on identifying opportunities for Big Data in Medicines Development and Regulation.

  1. The 2016 EMA survey on Initial Marketing Authorisation Applicationhas been launched last week.

The enclosed applicants’ questionnaires have been prepared further to consultation with your EU industry associations and will be sent out electronically from 15 September onwards to all initial centralised MAAs applicants that are going through any of the following 3 key centralised evaluation phases:

  • Pre-submission – Validation phase
  • Primary assessment phase (Day 1 to Day 121)
  • Opinion finalisation phase (Day 121 – Day 210)

The survey will run from 15 September 2016 until 28 February 2017 and will take 10’-15’ to be completed by the applicants.

The results of the survey will be analysed over the period from March to May 2017, and the findings will be discussed with industry stakeholder associations in the stakeholder platform on the operation of the centralised procedure in Q2 2017.  A report summarising the findings will also be published on the EMA website.

In case you will need any EMA official references to this survey initiation, a brief communication summary will be posted on the EMA “Pharmaceutical industry” landing page when the first applicants will be reached out: http://www.ema.europa.eu/ema/index.jsp?curl=pages/audience/alp_audiencetype_000004.jsp&mid=

  1. We are pleased to share with you the latest invitation of the European Medicines Agency:  a multi-stakeholder workshopentitled  “Identifying Opportunities for ‘Big Data’ in Medicines Development and Regulation” to be held on 14-15 November, at the EMA’s offices in London.

This field is evolving quite quickly in many areas and while the application of big data in healthcare promises huge opportunities, it is also recognised that there are significant challenges in its exploitation. As such, it is important for the European Medicines Agency and the European regulatory network to gather information on the latest developments in the field of big data in order to understand how and when the multitude of different data sets may contribute to medicinal product development, authorisation and post marketing surveillance.

This meeting is intended to stimulate new thinking and ultimately address some key questions that will inform on next steps. The workshop will be launched with a series of talks to provide an inspiring overview of the field of Big Data, outside of the field of healthcare, in order to understand the potential possibilities before focusing down onto how and when Big Data can contribute to medicinal product development, authorisation and post marketing surveillance. A series of case studies will be presented to inform on what are the latest trends and innovations and, bearing in mind the significant challenges, what are the opportunities before further sessions addressing “How we transform Data to Knowledge” and “Reconciling Big Data and Privacy”.

The Agenda of this workshop is being finalised and will shortly be made public in the EMA’s website.

The EMA is expecting significant interest in the workshop and is therefore planning to broadcast the workshop live and also record it for future reference.

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Published on 20. September 2016 in News EU