2-Day Medical Device Studies Training Course: Regulatory Requirements And Adverse Event Reporting (Online: Sept 17Th-18Th, 2026)

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, May 11, 2026 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting (Sept 17th - Sept 18th, 2026)" training course has been added to ResearchAndMarkets's offering.

Delve into the intricacies of medical device clinical evaluations, clinical investigations, and Post-Market Clinical Follow-up (PMCF) studies with our specialized course. Designed for professionals navigating the complex landscape of medical device regulations, this program emphasizes adverse event reporting requirements that are crucial during these studies.

With a focus on the recently implemented Medical Device Regulations (MDR), our course offers critical insights into the evolving regulatory framework, ensuring professionals remain agile and compliant. While our primary emphasis is on current MDR standards, we integrate valuable references to existing Medical Device Directives to provide historical context and further understanding.

Given the ever-expanding global market, this course also addresses the significant post-Brexit implications for medical device management in both the EU and the UK. Participants will gain an understanding of the new dynamics introduced by the UK's departure from the EU, equipping them with the knowledge to navigate and manage regulatory requirements effectively across these regions.

Our meticulously designed curriculum not only covers theoretical aspects but also hones practical skills, ensuring participants are well-prepared to manage clinical evaluations and investigations. This includes mastering processes related to adverse event reporting, a critical component of maintaining compliance and safeguarding patient safety.

With 12 Continuing Professional Development (CPD) hours accredited to this course, professionals can enhance their expertise and achieve personal career milestones while contributing to the broader field of medical device regulations.

Embark on this knowledge-enriching journey to refine your capabilities, stay updated with regulatory advancements, and maintain a competitive edge in the medical device industry. Our course is an essential investment for those committed to excelling in an industry pivoted on innovation, safety, and compliance.

Join us to fortify your understanding and ensure the highest standards of practice in medical device management during this transformative regulatory era.
Who should attend?

• Regulatory affairs specialists
• Quality assurance specialists
• Clinical research associates
• Junior clinical research associates
• Professionals involved in reporting adverse events during pre- and post-market clinical studies

Key Topics Covered:

• Day 1
  • Clinical evaluation - an overview
  • Clinical investigations - an overview
  • PMS and PMCF
  • Quiz on clinical evaluation, clinical investigation and PMCF
  • New requirements of the MDR
  • The competent authority and the Notified Body
  • Workshop on the new requirements of the MDR
• Day 2
  • Vigilance reporting
  • How to define and classify adverse events
  • Vigilance workshop
  • The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies
  • The MDR - clinical elements

Speaker

Graeme Ladds,Director of PharSafer, has over 30 years' experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.

Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug-device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.

For more information about this training visit

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