Elina is a member of the IP/Tech practice group and specialises in advising companies operating in the pharmaceuticals and medical devices sectors on the various regulatory issues they come across on a daily basis. She has advised both UK domestic clients as well as multinationals operating across borders. She works closely with specialist colleagues across Baker & McKenzie's global healthcare network.
Elina has also significant regulatory experience on cross-border mergers and acquisitions in the pharmaceutical and healthcare sector, particularly on international carve out and integration transactions.
Representative Legal Matters
- Secondment to a major US pharmaceutical company, being legal counsel for the UK where implemented UK compliance ABPI processes, assisted with UK launch and with various other matters in respect of ABPI compliance, GDPR, contracts review etc
- Seconded to a major multinational pharmaceutical company, and specifically to the EMEA regulatory department where was assisting with all applicable regulatory matters for oncology products such as compliance with the ABPI Code, PSPs programmes, marketing campaigns etc.
- Advising global pharmaceutical companies and multinational medical devices manufacturers on a range of regulatory issues including advertising and promoting medical and healthcare products, CE marking and MAs, obtaining regulatory licences such as distribution or manufacturing licences, clinical trials, as well as general regulatory compliance and advise on inspections and supply chain issues.
- Advising specialist technology companies on entering the regulatory regime covering medical devices, including in light of the new EU Regulations.
- Providing regulatory support and advice on corporate transactions involving pharmaceutical, medical devices and healthcare companies.
- Coordinated the global regulatory team in undertaking the regulatory actions required for the separation of Baxter's biopharmaceutical business, including with respect to MA transfers, import and export requirements, regulatory key personnel, distribution license transfers/applications, manufacturing license transfers/applications, establishment licenses, name changes and transitional arrangements.
- Coordinated global advice for Baxalta on the global regulatory impacts of the name change of manufacturing entities, including detailed analysis of different options to achieve the name change with minimum supply chain and labelling impacts in over 30 jurisdictions.
- Acting for Shire in connection with the regulatory integration steps following its acquisition of Baxalta, including with respect to MA transfers, regulatory key personnel, distribution license transfers/applications, manufacturing license transfers/applications, establishment licenses, name changes and transitional arrangements.
- Overseeing the global company secretarial system for global pharmaceutical company.
- Advised global organisations and coordinating projects on corporate governance issues, including director duties, setting up appropriate risk oversight controls and board succession planning strategies.
Elina has participated in the "Legal Experts in Schools", a volunteering programme aiming to increase young people's awareness and understanding of the law and helped with other law clinics matters. Elina is also a member of the pro bono team in Baker McKenzie in respect of the "Global Rights for Women".
- England & Wales~United Kingdom
- University of Glasgow (LL.M. in Corporate & Financial Law) (2012)
- Aristotle University of Thessaloniki (Bachelor of Laws) (2010)