WORKING WITH STAKEHOLDERS TO IMPROVE AVAILABILITY OF MEDICINES IN THE EU

Europe – WORKING WITH STAKEHOLDERS TO IMPROVE AVAILABILITY OF MEDICINES IN THE EU

The Task Force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines  is organising a two day-workshop (8-9 November 2018)...
EMA Issues Guideline on GVP Considerations for Pediatric Populations

Europe – EMA Issues Guideline on GVP Considerations for Pediatric Populations

The European Medicines Agency (EMA) on Wednesday released its recently adopted guideline on good pharmacovigilance practices (GVP) module providing recommendations for pharmacovigilance in pediatric...
NICE says no to expanding use of AZ’ Lynparza

UK – NICE says no to expanding use of AZ’ Lynparza

The drug’s recent expanded approval in Europe allows its use for maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal...
Industry Finds Fault With UK Vision for Drug Regulation After Brexit

UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit

British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The...
NICE nod for Jazz’ AML chemo

UK – NICE nod for Jazz’ AML chemo

In a Final Appraisal Determination the Institute has approved funding for the drug when used to treat adults with newly diagnosed, therapy-related t-AML or...
Organs, Tissues and Cells - Technical Guides

Europe – Organs, Tissues and Cells – Technical Guides

Guide to the quality and safety of organs for transplantation Transplant medicine and transplantation have progressed during the last decades in a way that nobody would...
EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India

Europe – EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India

A handful of statements of non-compliance with good manufacturing practice (GMP) have been posted to the EudraGMDP database, including ones sent to Spain’s Genfarma...
Supply unlicensed medicinal products (specials)

UK – Supply unlicensed medicinal products (specials)

Details This Medicines and Healthcare products Regulatory Agency (MHRA) guidance is for those who want to manufacture, import, distribute or supply unlicensed medicines for human...
NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer

UK – NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer

According to the Institute, while Caprelsa (vandetanib) may delay the disease getting worse compared with best supportive care, “but the benefit is uncertain”. Also, it...
EMA’s Rasi on Genome Editing: Time to Move Forward

Europe – EMA’s Rasi on Genome Editing: Time to Move Forward

For genome editing technologies in drug development, the European Medicines Agency’s (EMA) executive director Guido Rasi said recently that it’s time to not just...

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