Course overview
On 1 July 2015, the Common Arab Guidelines on Good Vigilance Practices came into effect, marking a significant transformation in pharmacovigilance across the region. Closely aligned with key aspects of the June 2012 EU guidelines, these regulations introduced a new era of standards, expectations, and regulatory oversight.
This intensive two-day course brings these guidelines to life, exploring each topic through a practical, real-world lens. Designed with a strong focus on compliance with Regulatory Authority requirements, the programme goes beyond theory to examine how the guidelines are applied in practice. Participants will gain valuable insights drawn from inspection and audit experiences following implementation, with a clear focus on the areas most frequently highlighted in inspection findings.
CPD Hours: 12
Course Content
- Day 1
- An introduction to the PV structure
- Quality management systems (QMS)
- The Pharmacovigilance System Master File (PSMF)
- Pharmacovigilance inspections
- Pharmacovigilance audits
- Day 2
- Risk Management Plans (RMPs) and risk minimisation
- Adverse reaction reporting (part 1)
- Adverse reaction reporting (part 2)
- Periodic Safety Update Reports (PSURs)
- Signals and their management and safety communication
Speakers
Graeme Ladds
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.
