Brexit & TMC EU Services

TMC is perfectly positioned to support its clients, both within and outside of the UK, following the end of the Brexit transition period

The transition period that followed the UK’s withdrawal from the European Union (EU) came to an end on the 31st December 2020. As of the 1st January 2021, the UK is no longer part of the harmonised EU medicines network. Developers of medicinal products and medical devices should be aware of the impact that this change could have on the development and commercialisation of their assets.

For the UK, TMC is continuing to work on behalf of its clients to support new and ongoing UK and RoW clinical trials as well as working directly with the Medicines and Healthcare products Regulatory Agency (MHRA) on approvals for UK paediatric investigational plans (PIP), UK orphan drug designations (ODD) and UK marketing authorisation applications (MAA).

For the EU and RoW, TMC is perfectly positioned to provide seamless support to its clients based across the globe that are developing or commercialising medicinal products or medical devices in the UK, EU, USA etc. TMC Pharma (EU) Ltd, based in Waterford, Ireland, enables TMC to continue to provide its clients with services that require a presence in the EU, detailed below.

Legal Representative or contact person for Clinical Trials

The Clinical Trials Directive 2001/20/EC states that for clinical trials

“…the sponsor or a legal representative of the sponsor must be established in the Community.”

Similarly, when the new Clinical Trial Regulation (EU) No 536/2014 comes into effect, sponsors of clinical trials will be required to have either a designated EU legal representative or EU-based contact person. TMC can offer either service through its Irish entity TMC Pharma (EU) Ltd.

Acting as Sponsor for Orphan Drug Designations

The legislation on orphan medicinal products, Regulation (EC) 141/2000, states that the sponsor of an orphan drug designation (ODD) must be established within the European Economic Area (EEA).

TMC Pharma (EU) Ltd can act as sponsor of EU ODDs throughout a product’s development, up to the time of market authorisation and beyond, if required (see Acting as Marketing Authorisation Holder in the European Union).

Acting as Marketing Authorisation Holder in the European Economic Area (EEA)

The holders of EEA marketing authorisations granted under Directive 2001/83/EC or Regulation (EC) 726/2004 must be established within the EEA.

TMC Pharma (EU) Ltd can act as applicant and eventual holder of EEA marketing authorisations on behalf of its clients whilst alternative, more permanent arrangements are made.

Micro, Small and Medium Enterprise status

As a qualified micro/small/medium enterprise (SME), TMC’s EU presence also allows its ex-EU clients access to the SME incentives on offer from the European Medicines Agency (EMA) such as fee reductions and exemptions, access to workshops and training sessions and assistance with translations.

European Union Qualified Person for Pharmacovigilance (EU QPPV)

Directive 2001/83/EC states that the EU QPPV (and their back-up) must reside and operate in the EU, except that, following EEA agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.

TMC provides its clients with EU QPPV services through our Irish entity TMC Pharma (EU) Ltd.

Provision of a Qualified Person for Medicinal Product Batch Release

In accordance with Directive 2001/83/EC, the Qualified Person (QP) of the manufacturing and importation authorisation holder is responsible to certify that each batch of medicinal product for the EU market has been manufactured in accordance with EU Good Manufacturing Practice (GMP) requirements and the marketing authorisation.

TMC works with sites of import and QPs in a number of EU countries and is able to provide QP batch release services in the EU through its Irish entity.

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Elvetham Park Estate,
Fleet Road, Hartley Wintney,
Hampshire RG27 8AS
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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.