Key Principles of Pharmacovigilance MasterClass
9 – 10 February 2017
Hotel Mercure Wien Westbanhof – Vienna – Austria
Learning outcomes
Training schedule
Day one
09:30 Registration
10:00 A brief history of Pharmacovigilance
10:20 Regulations and Guidelines
11:20 The critical PV processes
12:30 Luncheon & Networking
13:30 PV regulatory portals & other PV tools
14:15 Effective Data Management
15:15 TEA/ Coffee break
15:35 Analysing Special Interest Cases
16:00 Workshop – Special Interest Cases
17:15 Close of the day
Day two
09:15 Risk Management Plans & Risk Minimisation
10:15 Signal Detection Strategies & Safety Communication
11:15 TEA / Coffee Break
12:30 Luncheon & Networking
13:30 The EU Pharmacovigilance System Master File (PFMS)
15:00 Close of the day
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Training description
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.
Get to know the Expert Trainer
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)
Who should attend?
Senior Pharmacovigilance Regulators and Inspectors, Pharmacovigilance and Drug Safety Officers, Regulatory Affairs Officers, Clinical Risk-Benefit Groups, Local Medicines Authorities, CRO and Consultants providing QPPV Services, Pharma Industry Heads, Directors and Managers OF:
- Compliance
- Drug Safety Officers
- Global Drug Safety Officers
- Heads of Safety and Pharmacovigilance
- Inspection and Audit
- International PV Auditors
- Lead Safety Scientists
- Medical Affairs
- Patient Safety
- Pharmacoepidemiology Pharmacovigilance
- Consultants
- Pharmacovigilance Managers
- Pharmacovigilance Team Leaders
- PSMF
- PV Quality System
- QPPV Personnel’s
- Regulatory Affairs Managers
- Safety & Risk management Safety
- Evaluation
- Safety Surveillance Senior Safety
- Specialists
- Signal Detection
Our events were attended by these companies
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FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up