PCI Clinical Services and its Guests discuss Brexit and its impact on Clinical Trials in the EU and UK
It is very hard for anybody not intimately involved with the European Union, the workings of the UK economy and the healthcare sector, to clearly understand the true facts, or indeed the advantages and disadvantages, of Brexit. One fact is clear, Brexit is happening in March 2019 and the UK will leave the European Union.
So what does Brexit mean for the pharmaceutical sector? As various bodies initiate debate and argument, leading to uncertainty, assumptions and surmising, it is becoming increasingly difficult to separate fact from fiction and understand the likely implications that Brexit will have on this sector.
With European Commission directives and cross-border collaborations currently in place, it is perceived that clinical supply chains will experience future challenges in terms of compliance with new rules and regulations that will be enforced post March 2019.
With the degree of ‘Brexit uncertainty’ appearing to be increasing, what is fact and what is fiction and what will be the impact on the pharmaceutical sector?
Join PCI Clinical Services and its guests for this panel-based webinar which will look to discuss the facts around Brexit. Current levels of uncertainty within post-Brexit clinical trial supply chains is leading to client, sponsor and patient concerns. In an attempt to address these fears, our speakers will also outline our risk mitigation strategy to ensure continuity of our clients’ supply chains and to allow patients to continue to access safe and effective medicines.
Dr. Fiona Withey, Managing Director, UK Clinical Services
Fiona gained a BSc in Biology and Chemistry followed by a PhD in Biochemical Engineering from the University of Wales. Prior to joining Biotec Services in 2007 as Director of Business Development, Fiona began her career as a Senior Scientist in research and development before gaining 20 years’ experience in Business Development, Marketing, Project Management and Operational roles within the pharmaceutical and diagnostics industries. In 2008, Fiona was appointed to the Board of Directors of Biotec Worldwide Supplies Group and was latterly the Operations Director prior to being appointed as Chief Executive Officer. Following the acquisition of Biotec by PCI in September 2014, Fiona is currently the Managing Director UK Clinical Services with responsibility for clinical services and sites within the International region. Fiona also serves as a member of the Wales Economic Advisory Board and the Welsh Government Life Sciences advisory panel.
Tristram Evans, Quality Director, PCI Clinical Services
Following the PCI acquisition of Biotec Services in 2014, Tristram was appointed the role of PCI UKs Clinical Quality Director whereby Tristram is responsible for PCI’s international Clinical Quality with regards to clinical trial supply services and activities. Tristram is an EU Qualified Person (QP), qualifying under the permanent provisions in 2011. Tristram is responsible for the QP certification of both commercial and investigational medicinal products on licences he is named upon within PCI’s UK facilities. Tristram joined Biotec Services in 2007 as Quality Assurance Manager, and was promoted to the Quality Director role in July 2011. Prior to joining Biotec, Tristram worked in various positions within the pharmaceutical industry within Quality Control and Quality Assurance positions at Penn Pharmaceuticals and Norgine Ltd.
Dr. Peter Clarke, SVP CMC, PsiOxus
Dr. Peter Clarke has worked for over 30 years in the BioPharmaceutical industry for both multi-nationals (such as Bayer and Chiron) and start-up organizations. Most recently Dr Clarke was VP of Technical Operations for Insmed Inc. in New Jersey, progressing their first-in-class inhaled liposomal antibiotic formulations. He has been responsible for developing processes and building manufacturing organizations in Europe and the US and has successfully submitted Manufacturing Authorizations to a number of Regulatory Agencies including the FDA and EMA. In his role as VP of Production and Technical Processes at Introgen Therapeutics Dr Clarke was responsible for the optimization of adenoviral vector manufacture and the design and build of a BSL 2 production facility in Houston, TX. He has a BSc in biochemistry and obtained his doctorate in microbial physiology from The Imperial College of Science and Technology in London.”
Tony Street, Global Head of Solutions Consulting, PAREXEL Clinical Trial Supplies and Logistics
With over 20 years of experience in the pharmaceutical industry, Tony Street’s career spans Hospital Pharmacy, Clinical Trial Supplies (IMP) Project Management, GMP Operations, CMC Support and IRT Project Management. He has held a variety positions within the NHS, GSK, Allergan and CMO service providers before joining PAREXEL where he is now the Global Head of Solutions Consulting for PAREXEL’S Clinical Trial Supplies & Logistics services. Tony’s extensive experience has led him to specialize in supply chain & organizational optimization, system’s implementation & supply chain continuity planning.
Ian Price, Director, CBI Wales
Ian became Director CBI Wales in January 2017 after 11 years of being Assistant Director for both Wales and South West of England. Ian joined the CBI as Assistant Director in September 2005; Ian’s role initially in the CBI involved supporting Welsh and South West businesses with local and national government interface. Ian has always had a keen interest public sector procurement issues, he also has a broad knowledge in HR and Employment and Ian also established the CBI Wales Enterprise Forum which is now one of the pre-eminent voices on behalf of SMEs in Wales.
Ian currently sits on behalf of the CBI on the Secretary of State for Wales Expert Implementation panel on Brexit and on the First Minister for Wales Social Partners Strategy Group. He commentates on behalf of the CBI in the media and writes a regularly for business magazines, local and national press on business related issues.
Who Should Attend?
Senior professionals from Pharmaceutical, Biotechnology and Medical Device manufacturers involved in:
- Clinical supply chain / distribution / procurement
- Clinical packaging / labeling
- Clinical operations
- Quality assurance
- Regulatory affairs
PCI Pharma Services
PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.
Our core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply. We partner with clients in providing innovative technologies, flexible solutions, and an integrated supply network supporting life-saving medicines destined to more than 100 countries around the world.
We are dedicated to supporting clients with specialist experience, exemplified in our operational flexibility, delivery and commitment to safety – supported by industry-leading technologies and an exemplary quality and regulatory record. This has allowed us to be the partner of choice for leading pharmaceutical companies around the world, operating as a seamless extension of their business.