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EIPG endorses key events organised by membership

The European Industrial Pharmacists Group has recently had the pleasure to endorse two events organised by its members: the 18th Panhellenic Pharmaceutical Congress and the conference “European Clinical Trial Day,  the future of clinical research: is the 536/14 regulation enough?”

Italy. Towards a new governance for the pharma sector

The “Documento di economia e finanze 2017” (DEF 2017), issued in September by the Italian Government, is the programmatic financial document upon which will be based Italy’s Budget Law 2018 (“Legge di Bilancio”), to be approved by the Parliament before the end of the current year.

Regulatory challenges of CAR-T cell therapies

The first-in-class new chimeric antigen receptor T cell (CAR-T) cell therapy – Novartis’ Kymriah™ (tisagenlecleucel, CTL019) for children and young adults with B-ALL cell that is refractory or has relapsed at least twice – has received FDA approval at the end of August 2017.

The new ICH E11 (R1) on pediatric studies

After the public consultation phase in 2016, the ICH E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population closed step 4 of the ICH procedure in August 2017  and is now undergoing the implementation period (Step5)

Biosimilars to provide better access at sustainable costs

In the era of the personalisation of therapies, a better access to cure closely relates to the ability to sustain the very high costs of medicines that are far more sophisticaded than just some twenty years ago.

The Rx-mail order German affair

The sentence of the European Court of Justice of Oct. 2016 leaves still open in Germany the debate on how to handle the possibility to order Rx medicines online on foreing sites. Learn about the open issues and the possible solutions...

Many new clinical guidelines from EMA

Compliance of the trial master file and arrangements for the good clinical practice inspection procedures are discussed by new guidelines recently released by the European medicines Agency. Learn about the new requirements...

A new president for the French Association of Pharmacists

Jean-Pierre Paccioni has been elected as the new ad interim president of the French Pharmacist Association, in substitution of Isabelle Adenot who leaved to join HAS. He will remain in charge until the new elections will take place...

The dispute on CRISPR-Cas9 patents is still open

The Broad Institute is the winner of the first round of judgement on CRISPR-Cas9 patents. But the battle is far to be at the end, and new legal actions are expected by the University of California’s leaded group. Learn more about the current status of a dispute that could change the future of medicine...

The 2017 European Semester Country Reports

The 2017 European Semester Country reports published by the European Commission indicates the need to complete the reform of healthcare systems to progress towards cost-effectiveness and access to services. Many different measures are mentioned, according to the actual situation of the various countries...