Regulatory Affairs News - Paramount Recruitment

The work of the CHMP in 2012 and beyond was discussed at the recent TOPRA/EMA joint meeting read more

At the recent TOPRA joint meeting with EMA, Noel Wathion (EMA) highlighted the challenges for EMA in 2012- 2013 as it adapts to the changing environment. Budgetary cuts may lead to reprioritization and reallocation of resources in order to meet the challenge of implementation of the new Pharmacovigilance legislation. The need for more transparency in the wake of the Mediator case has resulted in ...

Fiona Reekie (Janssen Research& Development) and Xavier Luria Oller (EMA) chaired a session looking at how critical decisions are made on new medicines and the role of patients. read more

The European Medicines Agency has recently released a draft concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance. The document is available for consultation. here read more

This newsletter is addressed to patients, consumers and healthcare professionals' organisations and is intended to provide a monthly update on key information on human medicines produced and published by the European Medicines Agency. The information contained in each issue has been selected based on recommendations from consulted patients, consumers and healthcare professionals and is not intende...

TOPRA is pleased to announce that Samarind, a leading provider of software to the Regulatory Affairs profession, will sponsor the Innovation category of the 2011 Regulatory Affairs Awards. Lynda Wight, TOPRA’s Executive Director expressed delight that a winner in the 2010 Awards has agreed to support the 2011 event, adding ‘these Awards celebrate the very best in the world of regulatory affai...

The EU Clinical Trials Register was launched today by the European Medicines Agency (EMA). The online register gives for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried out ...

The European Medicines Agency has recently published a draft concept paper on potency declaration/labelling for biological medicinal products which contain modified proteins as active substance This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical recognised unit e...

The European Medicines Agency has recently published a draft "Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues". read more

The European Medicines Agency has recently published a draft guideline providing standard texts for warning statements on transmissible agents to be included in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. The original guideline (CPMP/BPWG/BWP/561/03) was adopted by CHMP in October 2003 and came into operation in May 2004. This revision aff...