EMA to host workshop on prevention of product shortages due to manufacturing and quality problems

A workshop on prevention of product shortages due to manufacturing and quality problems will be held at the European Medicines Agency (EMA) on Monday 14 October 2013.

The workshop, entitled 'Product shortages due to manufacturing and quality problems: Developing a proactive approach to prevention', will discuss how to improve existing risk-management strategies to prevent shortages due to manufacturing and quality issues, and how to mitigate the impact of shortages.

Over the past few years, there have been a number of public-health crises caused by supply shortages of medicines as a result of manufacturing and good-manufacturing-practice (GMP) compliance problems. In November 2012, the EMA published a reflection paper on supply shortages due to manufacturing or GMP-compliance problems . An action point from this paper was for the EMA to organise a workshop to raise awareness of the impacts of shortages and stimulate a response from industry and improvements to business-continuity planning. This is expected to help ensure that patients have access to essential medicines.

Participants at the workshop will include representatives from industry, patient and consumer groups, healthcare-professional bodies and regulatory authorities.

The event will be held from 9.30 to 17.00 (United Kingdom time) at the EMA in Canary Wharf, London. Participation is by invitation only. The workshop will be broadcast live on the EMA website, and the meeting outcomes and presentations will be published following the meeting.