Tune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health Data Space proposal and Brexit.
Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.
Marie provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.
She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective.
Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.
She is associate co-chair of Covington’s Food, Drug, and Device Rapid Response team during the COVID-19 pandemic.
CJEU Confirms that CBD is Not a Narcotic Drug
In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions. This is the case even where the CBD is derived from the whole cannabis plant. The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union. This is likely to have wide implications for the CBD industry.
Continue Reading CJEU Confirms that CBD is Not a Narcotic Drug
Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic
On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA). The Guidance is an update to the previous version published in late March (see InsideEULifeSciences…
Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations
The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19.
The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19).
Applications for clinical trials of human medicines or clinical investigations of medical devices…
MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19
On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19. The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with…
EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic
On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance). The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).
The Guidance provides information on changes and protocol deviations that…