Course overview
On 1 July 2015, the Common Arab Guidelines on good vigilance practices became effective. The Guidelines represented fundamental changes to pharmacovigilance practice and followed many aspects of the EU guidelines of June 2012.
This intensive two-day course will look at the various topics and their practical application from the perspective of compliance with the requirements of the Regulatory Authorities. The course will include experiences of the inspections and audits following implementation and will identify what the main focus points have been for possible 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.
