Retrospective MEB eDay 2017: Change in sight

In order to respond to e-developments, it is important that the information provision by the Medicines Evaluation Board (MEB) can adapt to these changes. During the eDay on 23 February 2017, the MEB presented its vision for the future (I-vision) and what this means for the pharmaceutical industry. Other important themes for the day were knowledge exchange and collaboration.

Joris Kampmeijer, Manager of the Programme Bureau Operational Management, kicked off the morning with a presentation on MEB’s vision on issues concerning information provision. It is important that all key players within the MEB and beyond receive optimal support during the entire authorisation process: from supply and processing to the exchange and sharing of information.

Jan Willem de Jong of the Programme Bureau Operational Management explained the developments concerning ‘CESP with 1 S’ and ‘CESSP with 2 Ses’ and talked about what this means for the development of a digital self-service portal for pharmaceutical companies. The MEB’s focus here is on Automatic Case Creation.

Stan van Belkum, Deputy Director, gave the participants insight into the EU Telematics Strategy beyond 2017, which clarified how the European vision and the MEB vision interact with one other. Joint basic principles include reduction of administrative burden, more efficient exchange of information and systems that are fully interoperable at the European level.

Information Manager Ricco van der Hoorn told participants about developments related to eCTD and VNeeS, what pharmaceutical companies can expect and what the consequences are for them. On 1 June 2017, the MEB will start with the technical validation of electronic submissions. From that date onwards, the MEB will only accept eSubmissions that meet the eCTD standard.

Nanneke Hendricks, Head of the Proper Use of Medicines programme, closed the eDay with a presentation on the communication of medicines information to patients and healthcare providers to promote proper use. The MEB is contributing to an environment in which patient information leaflets and SmPCs are searchable and navigable, information is reusable, and in which changes in product information are clear.