Visos naujienos

This October, the first ever Baltic States Regulatory Affairs Conference has gathered representatives from pharmaceutical industry, governmental institutions and external stakeholders from across Baltics and Europe in Vilnius, Lithuania.

The conference, organized by Innovative Pharmaceutical Industry Association (IFPA) and Pharmaceutical Manufactures Association (VGA) provided a unique opportunity for Baltic regulatory community to come together and prepare for the ongoing changes and future challenges.

The discussion has covered a range of topics, including  the future of drug development, how the European regulatory environment needs to evolve and change to increase the access to medicines, implementation of Falsified Medicines Directive, partnership opportunities and how to foster a Baltic regulatory direction currently and in the future.

Nick Sykes, Vice Chair of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Regulatory Strategy Committee, presented EFPIA's Regulatory Strategy to 2030 and gave an overview of the future of drug development.

EFPIA wishes to see Europe retain its role as an innovative regulatory region. EFPIA’s Regulatory Strategy 2030 aims to have a competetive and world-class regulatory system in Europe and beyond that embraces advances in science, technology and medicines, accelerating access to innovative healthcare solutions and optimised patient outcomes.

“It is important for us to understand, how the European regulatory environment needs to evolve to keep Europe at the forefront in the global context. At this conference, we had the opportunity to look at the broader context and see what steps need to be taken to reach the goals together. According to EFPIA's strategy, the collaboration among global authorities is very important, so we must pay attention to this,” says Agnė Gaižauskienė, Director of IFPA.

The participants focused on the importance of partnership and opportunities for collaboration, presenting a professional network of regulatory committees and its work in Europe.

“Changes in the regulatory affairs of the pharmaceutical industry across Europe need to be understood and implemented in a unified strategy. To be truly succesful in tackling the global healthcare and Regulatory challenges we are facing, we cannot do it on our own. We believe that collaboration is critical in finding the best solutions for patients and consumers,” says Evelina Dovidoniene, Chair of IFPA Regulatory Committee.

Experts also discussed regulatory optimization measures, such as innovative technologies, e-PIL, multilingual industry practices, which may have a direct impact on patients in the Baltic countries. The integration of innovation into the pharmaceutical industry and the modernization of tools could help to speed up drug registration processes, making them more accessible to patients.

Speakers also emphasized the benefits of modernising the regulatory network. According to experts, regulatory affairs need to evolve to fit with the digital age, which could increase connection and data quality and decrease workload, improve access to medicines and empower patients and healthcare providers.