3rd GBHI Conference
OVERVIEW
3rd Global Bioequivalence Harmonization Initiative (GBHI) Conference is organized by European Federation for Pharmaceutical Sciences (EUFEPS) and will be held during Apr 12 - 13, 2018 at Hotel Novotel Amsterdam City, Amsterdam, Noord Holland, Netherlands.
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.
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.
Additional details will be posted as soon as they are available.
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.
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.
Additional details will be posted as soon as they are available.
KEY DATES
12 Apr, 2018
Event Start Date
13 Apr, 2018
Event End Date
SPECIALITIES
Pharmacy and MedicineResearch and Clinical ResearchClinical PharmacologySUGGESTED HOTELS
CONFERENCE VENUE
Hotel Novotel Amsterdam CityRELATED CONFERENCES & LIVE WEBINARS
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