The scope of the of GLC’s Key Principles of Pharmacovigilance MasterClass is to provide a platform for managerial level of practitioners in the light of providing them the solutions to some of the pressing issues they face in their daily operations within the pharmacovigilance departments in the European pharmaceutical landscape.

The Training provides the participants a broad look of the key principles, some very important modules in the GVP legislation and a good grounding on the critical areas needed for PV from a leading subject matter expert. Attendees will also have the benefit of discussing emerging questions and network with their peers during our special networking sessions.

During the 2 day training participants can maximise their learning outcome through interesting case studies, workshops, brain-storming and interactive training sessions.

The training consists of not more 20 delegates in order to encourage knowledge acquisition and maximise the interaction with the trainer.

Learning Outcomes:

• New regulations in emerging markets
• Identify the critical processes required for any PV  system
• Eudravigilance as the key portal for PV
• Hear the best practices to ensure the quality of PV data for signal detection
• Investigate the  qualifications required for key staff members
• Understand how to raise  internal  awareness  about  the  role of PV within  the  organisation
• Learn how to implement and maintain the PSMF

The Trainer:          

Shirley-Ann van der Spuy

Profile

Shirley-Ann van der Spuy is the Managing Director of Red Line Pharmacovigilance Ltd. She is responsible for providing QPPV services and a range of other pharmacovigilance and medical information services for pharmaceutical  companies.

Shirley-Ann van der Spuy has a Bachelor of Pharmacy (BPharm), a Postgraduate Certificate in Pharmacovigilance and has Qualified Teacher Status through the Graduate Training Program. She has over 20 years of experience working within various sectors of the pharmaceutical industry having working across a range of key areas including GMP, GLP and regulatory functions. Shirley-Ann has worked as a community pharmacist providing valuable patient support to the end user, gaining an insight into the end-user experience of pharmaceuticals. This wide range of experience marries well with her current role as a QPPV, a position she holds for a number of generic pharmaceutical companies.  Shirley-Ann has set up and provided support to maintain European pharmacovigilance systems for pharmaceutical companies and generic manufacturers managing all aspects of pharmacovigilance within these systems.

Shirley-Ann is a member of the PIPA committee and co-chairman of the PIPA Training Working Party. In this role, Shirley-Ann has assisted with the development of training materials and presented at PIPA conferences. She has written various articles for PIPA, the Pharmaceutical Physician and has recently contributed a chapter titled ‘The Concept of Health’ for a book on global pharmacovigilance issues written by various members of ISoP and due to be published by Springer later this year.

As a business owner, Shirley-Ann has a good understanding of the challenges businesses face in maintaining regulatory compliance using cost-effective solutions. Shirley-Ann is a focused pharmacovigilance practitioner, passionate about sharing best practice and improving company strategies to build better internal pharmacovigilance awareness and ultimately improve patient safety.

Key Achievements

• Postgraduate Diploma in Pharmacovigilance – University of Hertfordshire
• ‘Introduction to Pharmacovigilance’ University of Hertfordshire (MSc Pharmacy Practice Module)
• Qualified and registered pharmacist with the South African Pharmacy Council
• Graduate Teaching Program & Qualified Teacher Status (QTS)

Current Role

Managing Director & EU QPPV

Red Line Pharmacovigilance Limited

Acting QPPV related tasks, Management of Pharmacovigilance Team, Medical Information Enquiry Handling & Literature Monitoring.

Professional Associations

• Member of the SAPC (South African Pharmacy Council)
• PIPA Committee Member (UK’s Pharmaceutical Information and Pharmacovigilance Association)
• Co-Chair of the PIPA TWP (Training Working Party) & Presenter on various PIPA training days.
• Member of ISoP (International Society of Pharmacovigilance)
• Member of RQA (Research Quality Association)