The Association Internationale de Standardisation Biologique pour L'Europe (IABS-EU) was created in April 2014. Its objective is to support the mission and projects of the International Alliance for Biological Standarization, to enhance its image and to develop its outreach within the European Union. IABS-EU contributes to scientific and medical advancement of biologicals by facilitating communication among those who develop, produce and regulate biological products for human and animal health. More specifically, it focuses on issues concerning the regulation and satndardization of biological products that are intended for market use.
Role of IABS-EU in VAC2VAC:
IABS-EU is leader of Work Package 6. Its role is to define a roadmap for regulatory acceptance of the consistency approach with the goal to provide a basis for guidance on regulatory implementation of new tests developed for the consistency approach; and to facilitate discussion between different stakeholders on specific questions and issues that the introduction of the consistency approach might raise. In collaboration with all partners of the VAC2VAC project, IABS-EU will evaluate progress and gaps in its regular meetings, build consensus to fill gaps and communicate progress with regulatory agencies and relevant EMA committees/working groups for future implementation, reach out to regulatory authorities when project results are considered sufficiently concrete and robust by the group or specific guidance is required, reach out with work package members to EDQM, USDA, FDA, WHO SAGE, WHO, WCBS, OIE, ICH/VICH, JEG3rs, etc. when project results are considered to allow such discussions in order to maximise impact, organise meetings and congresses for presentation and discussion of resluts and publication in biologicals, other editions if needed as well as through social media.
Dr. Joris Vandeputte has 19 years experience in the vaccine industry as global business director and international regulatory affairs director (Merial). He now coordinates regulatory affairs in ZAPI, the IMI project on prepardness for zoonoses. Doctor in Veterinary Medicine, a virologist, he was researcher, developer and disease control specialist on flue (both human and animal) rabies, TB, Brucellosis, Hydatosis etc. Regulatory expertise: responsibility for product registration at Rhone-Merieux, later Merial, as Director of Regulatory Affairs and Product Registration for Merial International. Main achievements: pandemic and zoonoses preparedness, vaccine development and market access.
Dr. Carmen Jungbäck, Dr. Pieter Neels, Jean-Marie Préaud