News

Last weeks round-up; 3 – 7 February 2020

published 10 Feb 2020

EMA ISSUES ACTION PLAN ON IMPROVING EU PRODUCT INFORMATION

The EMA recognises the importance of the European Commission recommendations to improve the EU product information. EMA see this as a unique opportunity to improve the information EU patients receive on their medicines, within the boundaries of the current legislation. The plan envisages;

      1. Many changes to Patient Leaflets (PLs) might not necessarily impact the SmPC.
      2. Actions to improve and update guidance and QRD templates in order to improve the readability of PLs.
      3. Proposals for more patient input to PLs. 
      4. Active promotion and exchange of best practice.
      5. Development of formats for SmPCs and PL.
      6. Introduction of key information sections to SmPCs and PL.

 

The action plans in full can be found under this link; https://lnkd.in/ekzb6Ye

MHRA GCP SYMPOSIUM

We’re proud to have our Real Expert, Dorothée Fouchier, on site at the Good Clinical Practice Symposium 2020 in London next week alongside our industry peers to discuss the integrity of data generated in clinical trials and to ensure that clinical trials are conducted according to regulations. If you’re also attending, get in touch! Dorothée would be pleased to see you there.

To arrange a meeting visit: https://lnkd.in/drv5fsr