Open Forum Discussion on the ICH Draft Guideline on the Bioequivalence of Immediate Release Dosage Forms
the draft of the ICH M13 Bioequivalence Guideline part A has been released for consultation in December 2022 on the ICH website. EMA published this draft later (February 7, 2023) and thus, the consultation phase for Europe was extended and set to May 26, 2023.
The scientific community is now invited to submit comments to the suggested regulations. There are some modifications in bioequivalence (BE) requirements, relevant for European companies which should initiate comprehensive scientific discussion. Examples are, amongst others, the proposed regulations on fed and fasting study conditions, the selection of the comparator product, the proposed regulations on fed and fasting study conditions, measurement of metabolites for BE assessment, “early exposure” and partial AUC as PK characteristics, multiple test resp. comparator products, or drugs with pH-dependent solubility.
The intention of this conference is to give scientists from industry and academia the opportunity to discuss the new regulations with European representatives of the ICH-Guideline’s drafting group. It will be organised as an “Open Discussion Forum” based on comments submitted to the organisers in the run-up phase to the event. Moreover, all participants are invited to present their views and suggestions, based on own experience, during the discussion and support these proposals by experimental data.
The Open Discussion Forum will take place on Monday, May 15, 2023 from 10:00 am until 16:30 pm.
Who should attend?
This Open Discussion Forum is designed to meet the requirements and expectations of professionals from the generic and the research-based industry, CROs, academia and regulatory agencies. Scientists active in e.g., regulatory affairs, formulation development, pharmacokinetics, clinical studies, and biostatistics should attend and contribute actively with their experience to the scientific discussions and thus, support the process towards science driven regulations.
We invite you to submit your comments to the EUFEPS-Secretariat (firstname.lastname@example.org) until April 30, at the latest.
Here you can download the actual version of the program: Download
Registration fees for the Open Forum
|Delegate Fees||Price [EUR]|
|Member early until March 30|
|Academia / Government||250|
|Member late after March 30|
|Academia / Government||400|
|Standard early until March 30|
|Academia / Government||320|
|Standard late after March 30|
|Academia / Government||470|
Registration fees are fully refundable until April 15. After that all fees are non-refundable; however, transfer of your registration to another person is permitted.
The event will take place at the Fraport Conference Center im Frankfurt Airport Center
Hugo-Eckener-Ring 1, 60547 Frankfurt a. M.
Please visit the following webpage to see how to reach the meeting place: See travel information