Tuesday, October 21, 2025

9:00 AM - 1:00 PM

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Details

Overview:  The workshop aims to provide pharmaceutical professionals with an in-depth understanding of pre-investigational new drug (pre-IND) meetings for the FDA and Scientific Advice Meetings in the EU, focusing on regulatory frameworks and strategic approaches the respective regions. As the pharmaceutical landscape becomes increasingly globalised, the need for effective communication and collaboration with regulatory authorities is paramount. Objectives: - To explore the purpose and significance of pre-IND meetings in the drug development process. - To compare the regulatory requirements and expectations for pre-IND meetings in the US and Europe. - To discuss best practices for preparing for and conducting successful pre-IND meetings. - To identify common challenges and strategies to overcome them in both regions. - To facilitate networking and knowledge sharing among participants. Target Audience:  This workshop is designed for regulatory affairs professionals, clinical development teams, heads of R&D. Format:  The workshop will include presentations from industry experts, case studies, interactive discussions, and breakout sessions. Participants will have the opportunity to engage in practical exercises to hone their skills in preparing for and managing pre-IND meetings. Outcomes:  Participants will leave the workshop with enhanced knowledge of the pre-IND meeting process, a toolkit of best practices, and a network of peers and experts to support their ongoing regulatory efforts.