Search Results for EMA guideline

Showing 1 – 5

EMA Drafts Guideline on RSV Treatments and Vaccines By Zachary Brennan - Published 31 October 2017

The European Medicines Agency (EMA) on Tuesday released for consultation a new guideline to help companies develop new medicines, direct-acting antiviral agents, monoclonal antibodies and vaccines to treat and prevent infections caused by the respiratory syncytial virus (RSV).

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: RSV medicines, EMA guideline

EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

EMA Offers Draft Guideline on Trial Master Files By Zachary Brennan - Published 13 April 2017

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: trial master file, EMA guideline

European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017) By Nick Paul Taylor - Published 06 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Government affairs

Tags: EU clinical trials, trial endpoints, EMA guideline

European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017) By Nick Paul Taylor - Published 30 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Submission and registration

Tags: EMA guideline, antibiotics, animal health