The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXb, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company.
This could will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products as well as Brexit and their impact on pharmacovigilance.
Programme to include:
This seminar will be beneficial to those who have some experience of veterinary pharmacovigilance and is a good follow-on course from the Introduction to Veterinary Pharmacovigilance, which is also run by Management Forum. Adverse event monitoring and drug safety officers, including QPPVs and Deputy QPPVs, together with personnel from regulatory affairs and registration departments will find this seminar useful.
The DDPS and the PV Master File
PV Training
Product Safety Reviews
Company Core Safety Information
Compliance and PV
PV Reporting in licensing/distribution agreements
Signal detection/benefit risk and risk management
Audits & Inspections: are you ready?
Declan O'Rourke
Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.
Declan is a veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and a Fellowship of the Royal College of Veterinary Surgeons. He now directs Ortec Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.
Declan is also an Honarary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School, Past President of British Cattle Veterinary Association and a member of the Veterinary Products Committee (VPC).
| 11-12 Dec 2019 | |||
| 11-12 Dec 2019 | Rembrandt Hotel, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Enrol now |
“Increase the number of practical/field examples. Very, very good. I like Declan's way to present and teach. ”
Luciano Gobbi, Associate Director Regulatory Affairs, MSD Animal Health SRL
“Good speaker, up to date materials and plenty of case studies. Excellent and very clear course, well delivered with plenty of opportunity for interactive discussion.”
Ruth Clements, Head of Pharmacovigilance, Benchmark
“I am very pleased to participate in the veterinary pharmacovigilance training by an expert in the field. The course materials were very well presented and the organization of the training course was perfect.”
Hyun Jung HAN GANNEAU, Pharmacovigilance Associate (Vet), AB Science
“Content was appropriate for the course title, it is a great follow on from basic training. Clear presentation, good clear slides, + Declan is always articulate + has a good way of explaining things especially when room is full of non native english speakers. ”
Jennifer Blenkinsop, Pharmacovigilance VRO, Veterinary Medicines Directorate
“Useful for my daily tasks”
Raffaella Focosi-Snyman, Pharmacovigilance HSO, Veterinary Medicines Directorate
“Very knowledgeable and friendly expert!!!”
Anna Sinjuk, Regulatory Affairs Specialist, Interchemie Werken De Adelaar Eesti AS
“Very thought provoking, many topics covered in detail, very friendly staff. Plenty of reading for me to do afterwards”
Nadine Anderson, Pharmacovigilance VRO, Veterinary Medicines Directorate
“Great speaker, very informative.”
Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate
“Good.”
Elisa Ursich, Pharmacovigilance - VRO, Veterinary Medicines Directorate
“Knowledgeable presenter with a lot of experience, nice to have regulators amongst us. ”
Angela van der Salm, Director Pharmacovigilance, DADA Consultancy
“I think the course is presented in a brilliant manner and contains great informative content. ”
Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate
“It is good course, covers major topics in PV. ”
Shahid Soomro, Head of Scientific Department , Bremer Pharma GmbH
“Interesting, engaging and very useful. I will be recommending it”
Caroline Mullen, Pharmacovigilance Officer, Boehringer Ingelheim
“There was a lot of examples and experiences told. Speaker was very available. ”
Tina Mele, Independent Researcher Drug Safety, KRKA d.d. Novo mesto
“Speaker speaks well and was open to our questions and concerns.”
Anu Miettinen, Drug Safety Expert, Oy Medfiles Ltd.
“Great course and great speaker”
Luis Marinas Pardo, Chief Scientific Officer, Centauri Biotech
“Overall, I think it was a very complete course, presented in an orderly and clean fashion. The speaker was very open for discussion and presented the course very lively.”
Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V.
“Content – good. Presentation and speaker - good presenting and discussion over issues raised by delegates ”
Lynne Braidwood, Lead Monitor, Veterinary Clinical Studies, Triveritas