(2012; 23 pages)
The 15th International Conference of Drug Regulatory Authorities (ICDRA) took place in Tallinn, Estonia, 23–26 October 2012. The event was hosted by the Ministry of Social Affairs and the State Agency of Medicines of Estonia in collaboration with the World Health Organization. It was attended by over 300 participants from 100 countries. The warm hospitality and excellent logistical support provided by the Agency was greatly appreciated.
The success of the ICDRA was again demonstrated by the increasing number of participants and its ability to respond to the needs and challenges of countries from all parts of the world through development of a relevant, balanced and up-to-date programme. The scope and diversity of topics responded to major trends encountered in the operation of medicines agencies including those issues having an impact on regulatory affairs in a globalized environment. The State Agency of Medicines also organized a one-day visit to their premises in Tartu to offer an overview of activities carried out by a small-country agency. The visit was attended by over 50 people including three from the US Food and Drug Administration.
Regulatory officials contributed to the programme sessions with technical presentations followed by focused discussion. Targeted recommendations were drafted which were considered important in raising awareness of the difficulties faced by agencies or which focused on the continuity and improvement of functionality, networking, collaboration and cooperation. These recommendations are set out below and on the following pages. Presentations made during the ICDRA are available on the WHO web site at http://www.who.int/medicines/icdra and on the ICDRA web site at http:// www.icdra.ee (for a limited time period of six months).
In addition, a pre-ICDRA meeting was convened, 21–22 October 2012, entitled «Quality of medicines in a globalized world: focus on active pharmaceutical ingredients ». The objective of the meeting was to offer an opportunity for greater interaction between regulatory officials and other interested parties, such as industry, civil society, scientific institutions and nongovernmental organizations. A brief summary and recommendations from the sessions is set out on pages 352–361.