Why collaboration and an Integrated Product Development program are key to successful drug development
The appointment of Laura Monkiene enhances the Regulatory Outsourcing Team
Frankfurt, Germany / Vilnius, Lithuania, November 23rd 2017: As of September 18th, 2017, PharmaLex Group, one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide, has enhanced its Regulatory Outsourcing Team with the addition of Laura Monkiene, a highly skillful senior expert and leader in the field of Regulatory Affairs with focus on Russia and the CIS region.
Laura Monkiene joins PharmaLex as Director/Principal Consultant. With her extensive experience, she will lead local and global projects and support clients worldwide with Regulatory Affairs, Medical Writing and Pharmacovigilance service demands. Laura brings along a great knowledge base has a clear understanding of the global and specifically Russia & CIS regulatory landscape. Her responsibilities will include management of new and strategically important projects, communication with regulatory agencies and management of local PharmaLex representatives in the CIS region.
During the last four years, Laura headed the Regulatory Affairs department at a company, where she was maintaining contacts with clients and regulatory agencies, managing a team of regulatory professionals and setting up new projects as well as conducting internal audits. Her experience includes solving complex issues, implementing various strategies in accordance to the clients´ needs and providing specific guidance.
“The CIS region is a growing and important market and we are building on Laura’s management capabilities to increase our local presence and team. We are excited to welcome Laura to the PharmaLex Group”, explained Dr. Kirsten Jacobs, Executive VP Regulatory Affairs. Laura added: “The CIS region is undergoing major changes in the regulatory framework related to the Eurasian Economic Union (EAEU) regulations. Exceptional focus should be given to new process´ implementation and re-registrations of current portfolios before December 31st, 2025. By strengthening our presence in the region we aim to support our customers to navigate through the changes as early and as comfortable as possible”.
Laura has a Masters Degree in Pharmacy from the Lithuanian University of Health Sciences and a second Masters Degree in Business Economics from Kaunas University of Technology.
The PharmaLex Group now has over 700 employees, with 26 offices in 14 countries and more than 600 satisfied clients worldwide.
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About PharmaLex <Confidence beyond compliance>:
Development Consulting, Regulatory Affairs, Quality Management & Compliance as well as Pharmacovigilance – are our core service areas. Whether you are looking for maintenance activities covering entire portfolios or are interested in bench-to-market guidance during product development and beyond, our worldwide teams are available when and where you need them. Our working models can be tailored to fit client needs to consistently deliver milestone achievements and exceed expectations. Our extensive experience covers all major therapeutic areas and most product categories beyond the traditional medicinal products, including advanced therapy medicinal products, orphan drugs, biosimilars and medical devices.
For further information, please contact:
Ms. Eva Keck
eva.keck@pharmalex.com
+49 621 18 15 38 158
Harrlachweg 6; 68163 Mannheim,
Germany
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