EMA 2025 Regulatory Strategy Shaping Future Public consultation human stakeholders workshop

EMA 2025 Regulatory Strategy

European Medicines Agency (EMA), has published its draft of ‘Regulatory Science to 2025’ strategy for a six-month public consultation, following the workshop organized last October. This “Reflection Paper” is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will […]

Chinese e-commerce ready to conquer the health market

With a value of 122.6 billion dollars in 2017, which in 2022 will reach a figure of 145 and 175 billion dollars, the Chinese pharmaceutical market was the second largest in the world, after the US. A huge development that has not gone unnoticed by Alibaba, the Chinese colossus of e-commerce, who last June after […]

Facebook MD Pharma Campaign - credits: Armando Testa.

Facebook opens to Pharma and MD ADV in Italy

Pharmaceutical and MD companies now have a brand new channel for their inbound marketing activities on the Italian market. In fact, after the new Advertising Guidelines issued by Italian Ministry of Health, Facebook decided to open their platform to Pharma OTC and OTC-MD adv campaigns: a huge B2C market is about to be at reach […]

GDPR General Data Protection Regulation PQE Pharma DOTS

EU: GDPR is now a reality

Published today in the Official Bulletin of the State, the legislative decree number 101/2018 aligns Italy to the GDPR rules that have been released on May 25th. The decree will be active from September 19, 2018 and aims to bring a step forward for the transparency in the relations between patients and health service; as […]

New GILS rules powered by PQE

PQE and SID&GP, together for Data Integrity guidance

PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS – Russian State Institute of Drugs and Good Practices. After the collaboration with COFEPRIS, the Mexican Regulatory Authority, for the creation of the data integrity chapter of the NOM […]

3rd PDA Europe Annual Meeting

Audit Trails Review: PQE leader of Pharma Coalition

On Wednesday 27th of June has been presented at the 3rd PDA Europe Annual Meeting in Berlin a white paper about the issue of the Audit Trails Review. The ongoing theme of the European Annual Meeting is Global Healthcare of the Present & the Future, as it intends to continue spanning a bridge between current […]

EMA moves to Amsterdam wins race over Milan

Amsterdam wins the race to EMA over Milan

Amsterdam – At the end of the line, Netherlands’ capitol city won with a ‘coin toss’ the EMA assignment over Milan at the very final rush, with just 502 votes for, 112 against and 37 abstained from the European Parliament session. It has been a tough race though, conditioned by the big delays encountered by […]