On 13 November, Farmak held an industry forum titled “Flexibility & Compliance: How to Maintain the Balance”, dedicated to International Quality Week. The event brought together representatives of government bodies, Ukrainian and international pharmaceutical companies, industry associations, and partners from related economic sectors.
Participants discussed key changes in pharmaceutical regulation, the adaptation of national legislation to EU standards, and the challenges accompanying the sector’s ongoing reform.
Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, shared plans to establish a unified State Control Authority (SCA) — a new regulator that will combine the functions of the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control.
Hennadii Vovk, Deputy Head of the State Service of Ukraine on Medicines and Drugs Control, outlined the changes already being implemented under the new Law of Ukraine “On Medicinal Products,” including updates to licensing conditions for manufacturing, wholesale and retail distribution of medicines, and the import of medicinal products.
Speakers also included Yevhen Khodnevych, Quality Director at Farmak, and Joanna Pakos, Director of Quality and Regulatory Affairs at Farmak International (Poland). They shared insights into the company’s experience in working with European pharmaceutical regulatory authorities during the export of Ukrainian medicines to the EU.
Nina Deputat, Head of the Registration Department at Acino Ukraine, spoke about the company’s approaches to regulatory interaction and offered her vision for improving processes for both business and the state.
In addition to keynote presentations, the forum featured two highly relevant panel discussions for quality and regulatory professionals:
• Mutual recognition of GMP certificates and new regulatory collaboration models
• Digital transformation: balancing automation, personnel, and regulatory requirements
“This year, our company celebrates its 100th anniversary. And it is precisely in this symbolic year for Farmak that we set out to create a space where regulators, businesses, and experts could come together to discuss how to adapt to European requirements while maintaining efficiency, and how to implement new approaches without compromising quality. The dialogue was truly meaningful. The main message that emerged is the need for cooperation and communication. Only through constant interaction can we gain deeper insight and implement changes that will strengthen the position of Ukrainian pharmaceuticals in the international market,” said Yevhen Khodnevych, Quality Director at Farmak.
A recording of the forum is available for everyone to watch via the link.
