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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) gained independence from the EU regulatory system in 2021, allowing it to make decisions about the approval of medicines in the UK without being influenced by the EU, except for in Northern Ireland, which is covered by the Protocol on Ireland/Northern Ireland. Throughout its the transition period out of the EU, the MHRA and the UK government made efforts to minimize this impact, with the MHRA now the standalone regulator in the UK.
Research from Imperial College London suggests the UK has fallen behind the EU in its first post-Brexit year when approving novel medicines, with 35 approved in 2021, compared with 40 in the EU and 52 in the US. This webinar will examine in detail the current state of play in medicine in the UK. Hear directly from key opinion leaders as they share insight into the latest regulatory issues.
The webinar will take the form of an online discussion examining:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Regulatory professionals looking to understand the current regulatory landscape for medicine approvals in the UK.
Justin HaySenior Director
Justin Hay completed his BSc (Biomedical Science) with majors in Pharmacology, Microbiology & Immunology (2001) and graduated with First Class Honours (2002). In 2007 he was conferred his PhD in Medicine (Pharmacology) from the University of Adelaide, Australia. His thesis investigated the pain sensitivity of chronic opioid users and explored novel pharmacological analgesic strategies for these patients. From March 2007, Justin was in the position of Senior Clinical Scientist at CHDR, where he investigated how biomarkers of the central nervous system could be used as a screening tool in early drug development, with a particular interest in analgesics and pain models. In 2011 he was awarded his Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and in 2014 was awarded the Graduate Certificate (with distinction) in Clinical Pharmacology from King's College London. Since October 2015 worked as Pharmacokinetics Assessor for the Medicines and Healthcare products Regulatory Authority (MHRA), UK, being a member of the EMA’s Modelling and Simulation Working Party (MSWP) during this time, from 2020 he was Senior Pharmacokinetics and Assessor Deputy Unit Manager (PLAT2) and had a leading role with the Access Consortium (Regulatory agencies of Australia, Canada, Singapore, Switzerland and UK). He join Certara in February 2022 as Senior Director, Clinical Pharmacology in the Integrated Drug Development Group. He is the author of over 70 peer reviewed abstracts/manuscripts in the field of clinical pharmacology.
Daniel SmithDirector, Regulatory Strategy
Over 20 years in the industry; from a lab-based non-clinical pathology start, to quality management, safety management and regulatory affairs. Experience across ATMPs to consumer healthcare for small biotechs through to blue chip pharma, in senior management, leadership and consulting positions. Until recently working at the forefront of microbiome science, exploring immuno-oncological, neurodegenerative CNS and gastrointestinal indications. Now working on orphan drug development in the EU and US, as well as a number of clinical programmes in support of similar developments.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.