Participation in European Medicines Agency procedures, when performing the function of senior preclinical expert

This tender concerns the participation in procedures of the European Medicines Agency (EMA) related to the senior pre-clinical expert function. Specifically, it involves participation in the central registration procedure for the medicinal product "Lyrokaul" under Procedure Number 6694. The role of the senior pre-clinical expert is crucial in evaluating the safety and efficacy of new medicinal products before they can be approved for human use. This typically involves reviewing extensive pre-clinical data, including toxicology, pharmacology, and pharmacokinetic studies, to assess potential risks and benefits. The expert will provide scientific advice and contribute to the overall assessment of the "Lyrokaul" application, ensuring compliance with regulatory requirements and scientific standards. The scope of work will likely encompass detailed analysis of submitted documentation, preparation of scientific opinions, and active engagement in discussions with the EMA's scientific committees and other stakeholders. This opportunity is vital for ensuring the quality and integrity of the drug approval process within the European Union, contributing to public health by facilitating the availability of safe and effective medicines. The successful participant will play a key role in the regulatory pathway for "Lyrokaul", requiring a deep understanding of pre-clinical drug development and regulatory affairs.

This is a services contract in the health and medical services and Research sectors, with a focus on Pharmaceuticals and Research Institutions. Located in Lithuania, Europe, this opportunity is open to firms and consortiums, with an estimated budget of EUR 10,975.

Published through TED - Tenders Electronic Daily (EU), a national government procurement portal. Public procurement tenders follow the country's national bidding regulations and may have specific eligibility and documentation requirements for services in the health and medical services sector. Service contracts are typically evaluated on both technical quality and price, and may require bidders to demonstrate relevant experience and qualified personnel. This contract has already been awarded. The information is published for transparency and market intelligence purposes.