- September 28 - 29, 2022
- Wed, Sep 28
- Thu, Sep 29
Goals and Objectives:
The goal of the Global Bioequivalence Harmonization Initiative (GBHI) conference is to offer the most informative and up to date science and regulation of bioequivalence in global drug development. GBHI workshop provides an open forum for pharmaceutical scientists from academia, industry and regulatory agencies to discuss various bioequivalence topics at issue for example, but not limited to (a) Fed vs fasted studies for immediate release dosage forms: relevance of excipients, disintegration/dissolution specificities, drug substance properties and physiological GI conditions; (b) Statistical considerations for BE assessment: replicate design for BE of Highly Variable Drugs, two-stage design and Pharmacokinetic modelling as supportive tools for BE assessment; (c) Topical products: Scientifically-based approaches for a waiver of clinical endpoint trials; (d) Narrow therapeutic index drugs: study design and acceptance criteria The presentations and discussions of these issues potentially enhances the mutual understanding of scientific background for bioequivalence evaluation and further facilitates harmonization of regulatory approaches for establishing bioequivalence of multisource drug products. The main goal of the workshop is to update participants on the national and international initiatives affecting the development of safe and effective pharmaceutical drug products via global bioequivalence harmonization initiatives. By the end of the program, the attendee will develop an appreciation and in-depth understanding of the continuous scientific and regulatory efforts to improve the quality of pharmaceutical products and their impact on pharmaceutical care.
The topics of this Workshop were selected by the Scientific Planning Committee (SPC) from FDA, AAPS and EUFEPS with the intention of providing a forum for open discussion, identifying differences with realistic chances for harmonization based on the scientific state of the art, and accelerating drug development by obtaining input from multi stake holder perspective.
Who Should Attend:
This conference is intended for leaders in Academia, the Pharmaceutical and Biotechnology Industry (PhRMA, BIO, GPhA), contract research organizations, API manufacturers, and domestic and international regulatory agencies in positions to affect the science and regulation of drug discovery and development, who wish to stay abreast of the national and international initiatives affecting the development of safe and effective pharmaceutical drug products.
If to FDA:
- Padmaja Mummaneni, Ph.D., 301-796-2027; email@example.com
- Mehul Mehta, Ph.D., 301-796-1573; firstname.lastname@example.org
If to AAPS:
- Tina Morris, Ph.D., 703-243-2800; email@example.com
If to EUFEPS:
- Barbara S. Schug, Ph.D. Mobile: +49-172-6742798; www.socratec-pharma.de
- Sandra Häberle, Ph.D. +49 69 719159620; Sandra.Haeberle@eufeps.org