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Wainwright Associates

Showing 10 posts of 10 posts found.

Submission of labels and leaflets in the UK

April 5, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Labelling, Wainwright Associates

The MHRA has announced procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets for medicinal …

News
Press release

On-going Medicine evaluation Information to be published by European Medicines Agency

February 24, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

Following the recommendations on transparency published by the European Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), …

News
Press release

MHRA Inspections of CROs

January 24, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Audits, Wainwright Associates, inspectons

In accordance with the provisions of the new pharmacovigilance legislation, as per Directive 2010/84/EU, EU Competent Authorities may inspect the …

News
Press release

Payment changes of authority’s fees in France

January 20, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates, regulatory affairs

Changes are being made in the way fees are paid for regulatory submissions and procedures in France.  Fees are no …

News
Press release

Changes to the EMA’s registration process for SMEs

November 22, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

The European Medicines Agency (EMA) has recently made changes to its process for the registration of micro, small or medium-sized …

News
Press release

Pharmacovigilance Compliance Report submission; MHRA’s Risk Based Compliance Programme

September 20, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing PV, Wainwright Associates

A new version of the MHRA pharmacovigilance Compliance Report (Good Pharmacovigilance Practice Questionnaire) has been released by the MHRA.Submission of …

News
Press release

First Paediatric Use Marketing Authorisation Granted

September 14, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

The European Commission has granted the first ever children’s medicine to hold a new Paediatric Use Marketing Authorisation (PUMA). The …

News
Press release

Joint API inspection pilot proves successful

August 17, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

Over recent years compliance with GMP in the manufacture of active substances (APIs) has been the subject of increasing regulatory …

News
Press release

Meet Wainwright Associates at the TOPRA Symposium and CPhl worldwide

August 7, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

Wainwright Associates is an independent company offering consultancy services to the pharmaceutical, medical device and healthcare industry in Product Development, …

News
Press release

EU Clinical Trials Register is Launched

March 29, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

The European Medicines Agency (EMA) has announced the launch of its EU Clinical Trials Register. This online register allows public …

News
Press release
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