3rd GBHI conference

 

 

 

Scope and aim

Assessment of bioequivalence is considered one of the key elements in the development and registration of new medicinal products. In case of generic drugs, it is the essential basis for product approvals worldwide. At the same time, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country and region to region. This does not only complicate the processes for pharmaceutical industry, but will also impede a comparison between products registered and marketed in different parts of the world. As the underlying scientific basis for deeming a new generic drug product as safe and effective is the same all over the world, it seems reasonable to expect that the experience gathered from regulatory procedures should be similar as well. Finally, ethical considerations should motivate regulatory scientists to collaborate with the intent to harmonize the criteria around the globe in order to avoid unnecessary repetition of BE studies only due to slightly deviating requirements.

Global Bioequivalence Harmonization Initiative (GBHI)

Already several years ago the European Federation for Pharmaceutical Sciences (EUFEPS), with its Network on Bioavailability and Biopharmaceutics (BABP) in the lead, has started an initiative to harmonize the requirements for bioequivalence assessment. This intention was from the beginning encouraged by the European Medicines Agency (EMA) as well as the US Food and Drug Administration (FDA). In order to support the intended process of global harmonization scientifically a series of International Conferences was started by EUFEPS in collaboration with the American Association of Pharmaceutical Scientists (AAPS). The first one was held 2015 in Amsterdam/The Netherlands followed by a second one 2016 in Rockville/USA. Both conferences were characterized by open discussions and constructive exchange between regulators, academia and industry and, thus, contributed significantly to the scientific debate on a worldwide harmonization of bioequivalence requirements. Also, regulatory scientists and speakers from other countries/regions, e.g. Canada, Chile, China, India, Japan, Mexico, and Brazil, attended and contributed to the discussions. Such global participation forms an ideal platform for scientists from the pharmaceutical industry and academia to exchange their experience and views with the regulators. Scientific consensus achieved at the end of processes such as these, should constitute the most appropriate basis for harmonization.

3rd GBHI Conference and expected outcome

This 3rd conference of the Global Bioequivalence Harmonization Initiative will take place in Amsterdam, The Netherlands, from April 12-13, 2018.

Topics of this conference were selected by an International Scientific Planning Committee with the intention of identifying differences with realistic chances for harmonization based on the scientific state of the art. To achieve this objective, the BE-related topics selected for discussion include the necessity of multiple dose studies in BE testing, the BE assessment of transdermal patches including adhesion and skin sensitization / irritation studies and BE of liposomal parenteral preparations. Moreover, aspects which remained still unresolved in the previous conference will be taken up again with the intention to achieve further consensus.

Based on the positive experience with the first GBHI conference 2015 in Amsterdam and the subsequent conference 2016 in Rockville/USA, the Scientific Committee expects intensive discussions between the regulatory scientists of the involved Agencies and the auditorium. Attendees may receive useful information for advanced designing of BE programs to find acceptance in all regions.

Broad Interest

This process should be in the interest of and supported by the regulatory side, industry and academia, on a global level. Scientists from all countries and regions of the world (Africa, Asia/Pacific, Australia, China, Europe, India, Japan, North and South America) are invited to contribute actively during the open discussions. Attendees are thus, encouraged to share their experience in the issues under discussion.

Conference chairs

Henning Blume, SocraTec C&S, Oberursel/Germany

Mehul Mehta, FDA, Silver Spring/USA

Scientific Planning Committee

Gerald Beuerle, Ratiopharm, Ulm/Germany

Henning Blume, SocraTec C&S, Oberursel/Germany (chair)

Mei-Ling Chen, Washington, USA

Barbara Davit, Washington/USA

Angelica Dorantes, FDA, Silver Spring/USA

Wenlei Jiang, FDA, Silver Spring/USA

Andreas Kovar, Sanofi, Frankfurt/Germany

Mehul Mehta, FDA, Silver Spring/USA

Henrike Potthast, BfArM, Bonn/Germany

Barbara Schug, SocraTec R&D, Oberursel/Germany

Tomas Salmonson, MPA, Uppsala/Sweden

Nilufer Tampal, FDA, Silver Spring/USA

Yu-Chung Tsang, Apotex, Toronto/Canada

Jan Welink, MEB, Utrecht/The Netherlands

Clive Wilson, Strathclyde University, Glasgow/Scotland

Organizing Committee

Sandra Wittmann, EUFEPS, Frankfurt/Germany

Henning Blume, SocraTec C&S, Oberursel/Germany

Mehul Mehta, FDA, Silver Spring/USA

Barbara Schug, SocraTec R&D, Oberursel/Germany

 

Venue

Amsterdam is unique among the European metropolises. Compared to other world cities, Amsterdam is quite small, but it offers all the advantages of a metropolis - a multitude of historical sights, world-famous museums and    a distinctive nightlife. The city itself has an international flair and offers something for every taste. Nothing is far apart and everything is well served by public transport.

The Novotel Amsterdam City is within walking distance of the city centre. The hotel is ideal for meetings and offers first-class meeting rooms.

 

For your hotel reservation, please use the this reservation form.

 

Registration and fees

Register now

                 EUFEPS Member

Standard

 

Early bird*

Late*

Early bird*

Late*

Industrial delegate

EUR 781

 

EUR 891

EUR 880

EUR 990

Academia and Government delegate

EUR 583

EUR 693

EUR 682

EUR 792

Student delegate

EUR 220

EUR 275

EUR 275

EUR 330

*All prices are excluding 21 % VAT

All tickets and congress papers will be handed to the participants upon check-in at the registration desk. Participants are requested to wear their congress badges at all times for identification and admittance to the conference rooms. Upon online registration, payment by credit card or bank transfer (free of bank commission) is possible. You will receive the invoice by regular mail.

Early bird until: January 5th, 2018, 08:00 CET

Online registration closes: March 16, 2018, 08:00 CET

 

Circulars and program for download

Preliminary program