Arriello Board Advisors Publish Timely Market Strategy Advice as Biotechs Review their International PV Obligations
New guide highlights the main differences in US/EU PV requirements and suggests a practical path for Biotechs to achieve multi-region compliance.
DUBLIN, Oct. 14, 2021 /PRNewswire-PRWeb/ -- Arriello, global experts in pharmacovigilance consulting and life science outsourcing services, today announced that two of its advisory board members have published a new, timely guide for biotechs looking to maximize their international market opportunity - without falling foul of the differing pharmacovigilance requirements across the major global regions.
Drawing on their respective experience on either side of the Atlantic, Dr Eric Caugant in Paris and Dr Judith M. Sills, Pharm.D. in New Jersey have highlighted the main differences between the US and European PV expectations, both pre- and post-market. The experts pooled their advice for ambitious young biotechs looking to capitalize on global opportunities when they typically lack the scale of PV resources of much larger life sciences companies.
Arriello, a leading provider of risk management and compliance services to the Life Sciences industry globally, prides itself on the deep expertise of its global team, and of its non-executive advisors who proactively contribute the latest regulatory knowledge and best practice from across North America and Europe.
Dr. Judith M. Sills, Pharm.D., based on the East Coast of the US, is President of JM Sills Consulting LLC, specializing in pharmacovigilance and benefit-risk management. She has over 30 years of experience in pharmacovigilance gained across her time in the pharmaceutical industry, as well as at the FDA, and in a consulting role. Prior to establishing her own consulting practice in 2018, Judi was Vice-President and Head of Global Pharmacovigilance at The Medicines Company.
Based in mainland Europe, Dr. Eric Caugant has over 25 years' experience in Pharmacovigilance, Drug Safety, Risk Management, and more broadly Pharmaceutical Medicine. In 2017, he founded Pharmacovigilance Systems Consulting (PhVSC). Eric has also held senior positions in various pharmaceutical and biotech companies, including Alexion, Bayer Lilly and Wyeth. He has also worked for the French Ministry of Health.
Arriello has two further Advisory Board members, who are equally proactive and engaged in bringing the latest Life Sciences industry insights to Arriello and its clients: Dr. John Price and UK-based, Dr. Panos Tsintis.
Dr. John Price is an executive physician with deep experience gained from over 25 years working across the breadth of regulatory affairs and pharmacovigilance worldwide. He has created and led high-functioning global departments for pharmacovigilance, regulatory and clinical operations, medical writing and drug development, and held senior roles in the UK Medicines Control Agency (now MHRA), Pfizer, J&J, Alexion Pharmaceuticals, and academia.
Dr. Panos Tsintis has more than two decades' experience of pharmacovigilance, regulatory affairs and pharmaceutical medicine experience, from drug development to post-marketing. Between 2002 and 2008 he was Head of Pharmacovigilance and Post-Authorisation Safety and Efficacy Sector at the European Medicines Agency (EMA). He has also held senior positions at the UK MHRA as well as in the pharmaceutical industry.
Commenting on the vital role played by Arriello's global Advisory Board, company CEO Alan White, says, "Judi, Eric, John and Panos bring exceptional and extensive global experience to help shape and direct our future pharmacovigilance strategy and operations. Each commands a unique high-level industry insight and particular geographical perspective, having between them worked with or for the EMA, FDA, MHRA, ICH, CIOMS and many other key organizations on national and global projects and initiatives.
"This latest guide, providing biotechs with timely PV advice and tips on internal market strategy planning, is another fantastic example of the value they add to Arriello and to our global client base. Their input, as ever, is invaluable."
A copy of Arriello's new international PV guide for biotechs, co-authored by Dr Judith M. Sills and Dr Eric Caugant, is available to download here
About Arriello
Arriello has been providing risk management and compliance services to the life sciences sector since 2008. These services include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety and quality and compliance auditing systems.
Headquartered in Ireland, with European operations in Central Europe, our technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
More at http://www.arriello.com and @Arriello
Media Contact
Carina Birt, Sarum PR, +44 7970006624, [email protected]
Gillian Reading, Sarum PR, 7799153550, [email protected]
SOURCE Arriello
Share this article