Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. Taking a medicinal product through clinical development is already a long, complicated and expensive exercise, but developing an ATMP is likely to be more complicated, more expensive and presents particular challenges and opportunities for pharmacovigilance and drug safety.
These challenges often take the form of:
- Idiosyncratic protocol design
- Proactive detection of risks
- Risk mitigation and treatment frameworks
- Long-term follow-up obligations
Register for this webinar to explore those challenges and the means to address those opportunities to add real value in the management of ATMP clinical trials.
Kieran O’Donnell, Principal Consultant, Pharmacovigilance, Arriello
Kieran O’Donnell is a Principal Consultant at Arriello, with over 20 years of broad PV experience in pharma, CROs, and management consultancy. Kieran is also an experienced auditor and QPPV with over 15 years of experience in those roles. Kieran has lead PV functions at VP & Director level for over 12 years, and during that time has led multiple and successful change projects.
This wealth of experience and knowledge helps Kieran understand and anticipate client needs, and tailor PV solutions accordingly.
Kieran’s free time is mostly spent with family, and when he gets a chance Kieran enjoys cycling and running.Message Presenter
Esther Poole, Managing Consultant for Clinical Safety, Pharmacovigilance, Arriello
Esther Poole is a Managing Consultant for Clinical Safety within Arriello’s Pharmacovigilance team, with extensive experience in both early phase clinical development and CRO environments.
Having worked within various roles in Clinical Operations and Medical Writing teams, before specialising in Pharmacovigilance, she has an established understanding of the role of drug safety in clinical and post‑marketing contexts, and a broad range of technical skills in both areas. She is particularly passionate about clinical drug safety, as well as project and client management.
Outside of work, Esther’s main passion is art and she enjoys anything creative. She also loves travelling and exploring new places.Message Presenter
Who Should Attend?
- Heads/Directors of Clinical development
- Heads/Directors of Drug Safety, Pharmacovigilance, Product Safety
- Heads/Directors of Clinical Project Management
- Chief Medical Officers
What You Will Learn
During this webinar, speakers from Arriello will share their insights on the following topics:
- ATMP trials: similarities and differences from traditional medicinal products
- General challenges associated with ATMP development and successfully bringing that product to the market
- Specific PV challenges associated with ATMP clinical trials
- How Arriello works with the Sponsor to add value in addressing those PV challenge
Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry. We’ve been making the development-to-market process faster, better, and smarter since 2008.
Our global services span the product life cycle from Clinical to post-submission Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, and innovative automation solutions.
Headquartered in Ireland, with operations across Europe, we consult, create, and provide solutions across the EU, North America, LATAM, CIS, MENA, Asia, and South Africa.
With our extensive global network, decades of combined experience and ISO:9001 certification, we are a trusted partner primarily to pharmaceutical and biotech companies.
Our valued clients rely on our ability to deliver, however complex their requirements, through our proven expertise, global coverage, and technology.