MHRA MA application validated

TMC Pharma Services has received confirmation from the Medicines and Healthcare products Regulatory Agency (MHRA) that our recent application, made on behalf of one of our longstanding clients, for a Great Britain Marketing Authorisation (MA) under the MHRA’s new European Commission Decision Reliance Procedure (ECDRP) has been successfully validated.

The ECDRP came into effect on 1 January 2021 and enables the MHRA to rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure. The MHRA aims to determine the Great Britain MA within 67 days and as soon as possible after EC approval.

TMC is proud to have been involved in this submission and looks forward to working with the MHRA toward approval.

Share the Post:
Facebook
Twitter
LinkedIn
TMC Pharma Services Ltd
Lodge Farm Barn
Elvetham Park Estate,
Fleet Road, Hartley Wintney,
Hampshire RG27 8AS
United Kingdom

Contact Us
+44 1252 842255
info@tmcpharma.com
Registered in the UK, No. 4241825

Privacy Policy
Cookie Policy
Site design: twofresh

Linkedin
Scroll to Top

Achi

Vice President Clinical

Victoria joined TMC Pharma in 2022, bringing with her over 20 years of clinical development experience within global clinical research, including both project management and line management.

A medically qualified doctor, her extensive experience covers all clinical trial phases across a broad range of indications and therapies with particular expertise in oncology/cell therapy.

Victoria’s Clinical Services team comprises experienced and highly capable Project Directors, Project Managers, CRAs and CTAs allowing her direct oversight and governance of all aspects of our projects.

Dr Victoria Datsenko

Vice President Clinical

Victoria joined TMC Pharma in 2022, bringing with her over 20 years of clinical development experience within global clinical research, including both project management and line management.

A medically qualified doctor, her extensive experience covers all clinical trial phases across a broad range of indications and therapies with particular expertise in oncology/cell therapy.

Victoria’s Clinical Services team comprises experienced and highly capable Project Directors, Project Managers, CRAs and CTAs allowing her direct oversight and governance of all aspects of our projects.

Quentin Clarke

Head of Pharmacovigilance

Quentin has been working in the pharmaceutical industry for over 30 years, starting in Medical Information at Leo Pharma, where he moved into pharmacovigilance. Subsequently, he moved to run PV departments in service organizations such as MDS Pharma and Aptiv solutions. He has been an EU QPPV for multiple projects and more recently a UK QPPV.

Quentin has vast experience in both pre-and post- marketing PV surveillance and case management. His very broad experience of course encompasses managing PSMFs, EU and local RMP documents, periodic reports etc. as well as signal detection /review processes.

Quentin joined TMC in 2020

Andrew Green

Head of Finance

Andrew started his career in a variety of roles including a significant period as a Junior Partner in accounting practice.

In November 1998 Andrew joined Quintiles, then the largest CRO, and since has had a varied career working in most of the service lines, including Clinical Operations, Centralised Monitoring, Data Sciences, Safety and Regulatory where he gained Orphan Drug experience, and therapy areas including Oncology, Cardiovascular and CNS.

Andrew has supported annual revenues of up to $1bn and teams of up to 9000 staff across the world.

Andrew joined TMC in November 2021. He is a Fellow of the ACCA.

Catherine Moncad

Head, Regulatory Services

With a Joint Honours degree in Biochemistry and Biology, Catherine entered the pharmaceutical industry taking a Data Management role at PAREXEL before moving to Regulatory Affairs, via R&D, at Reckitt Benckiser.

Catherine has since held regulatory roles at Dr. Reddy’s, Smith & Nephew, Chiltern and PRA gaining experience in OTCs, generics, devices, prescription pharmaceuticals and wide clinical trial experience.

Acting as Global Director of Regulatory Affairs at PRA, Catherine managed a team of ~50 regulatory affairs staff across the UK, Russia, Ukraine, Georgia and Germany.

Catherine joined TMC in March 2017.

Marcelo Vaz, MD, PhD, FFCP

Head, Medical Services

Having qualified in 1992 and with an early career specialising in Pulmonary academia and clinical practice, he moved to the pharmaceutical industry in 2007, initially as a Senior Clinical Research Physician before becoming a Medical Director at a large CRO.

Marcelo developed clinical research expertise across the range of respiratory diseases, including COPD, Asthma, Lung Cancer, Cystic Fibrosis, Respiratory infections, Sepsis, mechanical ventilation, ARDS and SIRS.

Other areas of clinical research experience include CV, TGI, rheumatology, woman’s health, oncology, ENT, CNS, DM. His rare diseases expertise includes supporting strategic creation of drug development plans, protocol concepts, and from classic to adaptive study designs.

Marcelo joined TMC Pharma in 2022.

Carol Woodward

Chief Operating Officer

After completing her initial degree at the University of East Anglia, Carol joined the pharmaceutical industry, working at Lederle Laboratories, Schering AG before joining Shire Pharmaceuticals. In the latter she contributed to the drug development process as a Program Leader. During this time Carol also completed an MSc in Clinical Research at the University of Wales.

Carol has extensive experience across many therapeutic areas, particularly oncology, and all development phases and held roles in both Pharmaceutical and Clinical Research Organisations including senior positions such as the Global Therapeutic Head of Haematology/Oncology at PPD and Vice President Development Innovations and European Operations at Sarah Cannon.

Carol joined TMC in March 2020.

Julie Matthews

Chief Executive Officer

Trained in microbiology, Julie ran an academic hospital research laboratory in Cambridge (UK) prior to joining Warner Lambert Clinical Development Group in 1986, where she ultimately became International Therapy Area Director. She then joined Rhone Poulenc Rorer in France, where she was involved first in oncology clinical development, and subsequently as Head of Anti-infectives Clinical Development.

Julie then joined Orphan Europe in Paris as Head of Clinical Development and Regional Business Manager, before going on to set up and run the company’s UK affiliate, as General Manager responsible for drug and business development, regulatory affairs, sales and marketing.

Julie started TMC in the year 2000.