MAPPs newsletter NEW HEADER
  NEWSLETTER October 2016  
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In this newsletter we look forward to the EMA Patient Registries Workshop to be held on 28 October 2016 at the EMA offices in London. The workshop is designed to bring together multiple stakeholders including registry owners, industry, HTA representatives and regulators to discuss the challenges and barriers to collaboration and identify specific solutions.
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  Blog Post
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“Using registries in real world evidence: Paving the path for success” by Emma Du four and Chris Chinn

On 28 October 2016, the European Medicines Agency (EMA) will hold the EMA registries workshop regarding the use of registries in real world evidence. In advance of this discussion, Emma Du Four, Senior Director Regulatory Policy & Intelligence at AbbVie, and Chris Chinn, Head of Real World Data Strategy and Partnerships at Sanofi, (Co-Chairs of the EFPIA-EBE-VE Real World Evidence-Registries Community), outline the key principles that need to be fulfilled for registries to contribute to the success of real world evidence.
 
When generating real world evidence on the impact of a disease or treatments for that disease, the utilisation of registries can be an efficient mechanism. Recognising this, the European Commission (EC) and European Medicines Agency (EMA) have increased their support of initiatives designed to enhance the utility of registries. Take, for example, the EMA patient registry initiative. This initiative is exploring ways of expanding the use of patient registries by introducing and supporting a more systematic and standardised approach to their contribution to the benefit-risk evaluation of medicines within the European Economic Area.

Certain challenges remain in the use of registries, however, both in terms of tapping into the potential of existing registries and establishing new ones. The upcoming October workshop will further the discussion on the use of patient registries as a potential “real world evidence base” and examine some of the hurdles at hand. As we prepare for these conversations, we would like to highlight some of the challenges identified by pharmaceutical companies and regulators in the use of registries, including:

  • The need for coordination between on-going initiatives at national and international levels;
  • A desire for harmonised protocols, scientific methods and data structures;
  • The importance of data sharing and transparency;
  • Concerns regarding sustainability.
READ THE FULL ARTICLE
 
 
 
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  EFPIA Brussels Office
 
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Leopold Plaza Building
Rue du Trône 108
B-1050 Brussels (Belgium)
Tel: +32 (0)2 626 25 55
E-mail:
anna.szczepanska@efpia.eu
or science-policy@efpia.eu
 
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