Industry representatives from EFPIA, EuropaBio and EGA are invited to attend the second day of the TIGes meetings, known as the Joint TIGes meetings.
EFPIA eCTD Topic Group
www.efpia.org
EFPIA represents the pharmaceutical industry operating in Europe. Through its members from 30 national associations and 43 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,100 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world.
The EFPIA eCTD Topic Group is the lead group within EFPIA concerned with issues around the implementation of the eCTD in the European region and provides support to the EFPIA experts at the ICH. Our group membership is made up from volunteers from the EFPIA member companies. We are charged with defining the EFPIA position and strategy around the eCTD and related e-submission topics and bringing this to the higher level Ad Hoc Groups and Policy Committees in EFPIA. We are also involved in the industry and agency groups working in this topic area and have been leaders and participants in the development of the strategies, specifications, standards and best practices around the implementation of the eCTD in Europe.
Europabio
www.europabio.org
EuropaBio is the association of bioindustries in Europe. The association has some 60 corporate members operating worldwide, 14 associates, 5 regions and 25 national biotechnology associations, representing 1,500 small and medium sized biotech companies in Europe.
Members of EuropaBio are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes. Our corporate members have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services. The common denominator among all our members is the use of biotechnology at any stage of research, development or manufacturing.
Within EuropBio are three groupings: white (industrial), green (plant/crop), and red (healthcare). It is the healthcare biotechnology group that is concerned with medicinal products and diagnostics. EuropaBio’s Legislative Working Group focuses on ensuring effective working relationships with EMA, CHMP, and the European Commission to create a positive regulatory environment for healthcare biotechnology products in Europe.
EGA
www.egagenerics.com
The EGA is the official representative body of the European generic pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector.
The EGA was established in 1993. The Association is established as an international non-profit organisation under Belgian law (ASBL). Its objectives, composition and internal working procedures are governed by its Statutes of Association and Rules of Procedure. Although formally based in Brussels, the EGA and its experts carry out activities throughout Europe in conjunction with the Association's member companies and associations. Companies represented within the EGA provide over 100,000 jobs in Europe.
The primary objective of the Association is to represent, support and develop the common scientific and technical interests of the European generic pharmaceutical industry and bulk chemical producers or national or European associations of such persons, firms, companies or other legal bodies active in the generic pharmaceutical or bulk chemical producers industries. (Article 3 Statutes of Association).
One of the six main activities of the EGA is to monitor, study and analyse those scientific, legal and technical developments at European and international level that impact upon the common interests of its membership. To facilitate this activity, the EGA has established five committees, one of those being the Regulatory and Scientific Affairs Committee (RSAC). The e-submission working group is a working group under the umbrella of the RSAC and consists of more than 10 participants from different members. The e-submission working group aims to inform EGA members of trends, developments and implications of any issues relating to electronic submissions impacting the generic pharmaceutical industry.
AESGP
www.aesgp.be
AESGP was founded in 1964 and is the European body representing manufacturers of non-prescription medicines. With its 27 national organisations and 20 associates, AESGP represents more than 1,000 small and medium-sized enterprises as well as the main international companies committed to responsible self-care. These companies provide high quality, safe and effective medicines available without prescription to the European citizens. They are widely recognised as an important contribution to public health throughout Europe.
AESGP is a member of the World Self-Medication Industry (WSMI), which articulates the views of the self-care industry at a worldwide level and enjoys non-governmental organisation status with the World Health Organization.
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