EIPG Newsletter

The new EU Commissioners for Health and Research: proposals and suggestions for their action

Stella Kyriakides from Cyprus and Mariya Gabriel from Bulgaria advanced the proposals for their mandate during the hearing at the European Parliament, and many other suggestions for their action came already from stakeholders

A Staff Working Document on EMA’s fees published by the EU Commission

The consultation on the Staff Working Document describing the possible scenarios for the revision of EMA’s fees system closed on 16 October. Three different levels of intervention were proposed by the EU Commission, from an action just on veterinary medicines to a complete re-thinking of the system to introduce more flexibility both for human and veterinary medicinal products

Science Europe’s report on interdisciplinarity of research

Interdisciplinarity of research is essential to answer complex scientific questions, but there is still lack of experts able to evaluate this kind of projects. The third Science Europe's Symposium discussed the main issues to improve interdisciplinarity, including new education curricula for young scientists

Verification, review, and check: approximation and implementation in terms of data integrity

Verification, review, and check are critical process to confirm data integrity, but their exact meaning is often not so clear. A brief excursus of recent articles discussing the issue

EIPG: Draft Code of Practice for Qualified Persons and other news from EIPG

Before the end of this year EIPG will finalise and publish the revised Code of Practice for Qualified Persons. A call for observations and proposals has been raised during the General Assembly in Budapest. The European Commission has published an updated version of Q&As document on the Safety Features. Upcoming webinars, Bureau or other news can be found at EIPG’s website, while past presentation slides and webinar recordings can only be found, at member’s area

MedTech Europe asks a better devices’ interoperability to pursue digital health

A call to action position paper by MedTech Europe discusses the different options to improve devices’ interoperability, among which overcoming data silos and market fragmentation, the availability of common standards and new investments in infrastructures

Latest advancements in the EU-US Mutual Recognition Agreement for Pharmaceuticals

Slovakia has been the last country to be approved by the FDA under the Mutual Recognition Agreement for Pharmaceuticals, that can now reach full implementation. Regulatory authorities will share results of inspections, and a batch testing waiver will also become active. EMA and the FDA are also well aligned as for decisions on the approvals of new medicinal products, says a recent study

PwC’s CEO survey 2019

The global economic and financial scenario is worsening, says the PwC’s CEO survey 2019. The main goal for healthcare companies is the safeguard of their brand value and reputation, but data available to fund analyses and decisions are still not considered adequate

EIPG: Upcoming webinar and news from EIPG’s website

The next EIPG's and PIER's webinar will see John Watson discussing features of the development and regulatory approval of orphan medicines. Questions have been raised at the EU Parliament about the lack of Notified Bodies to run the procedures needed to comply with the new Medical Devices Regulation. The EU Commission releases an updated version of EudraLex volumes 6A and 6C

Malta: Implementation of the Delegated Regulation on Safety Features

Maltese MaMVO extended six months the stabilisation period for pharmacies, while ending up that for wholesale dealers. In July a meeting of countries adhering to the Valletta Declaration occurred, aimed to achieve a better transparency on price negotiations