Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
23-24 Jun 2020
& 25-26 Nov 2020
GBP 1,399 1,199 *
EUR 1,959 1,679 *
USD 2,182 1,870 *
* When you book before 10 Apr
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. The programme will also consider the potential impact of Brexit on pharmacovigilance and the implications of the proposed EU Regulation (2019/6) on Veterinary Medicinal Products.
Interactive sessions throughout the two days will give delegates the opportunity to discuss key issues of current concern with our experienced trainer.
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 event useful.
The course can be used as part of the training to become a QPPV or deputy QPPV
The DDPS and the PSMF
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?
The implications of Brexit and new EU Regulation (2019/6)
Practical and interactive discussion sessions will take place throughout the two days
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).
| 23-24 Jun 2020 | ||||
| 23-24 Jun 2020 | Holiday Inn London - Kensington Forum, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
GBP 1,199.00 EUR 1,679.00 USD 1,870.00 Until 10 Apr* |
Enrol now |
| 25-26 Nov 2020 | ||||
| 25-26 Nov 2020 | Cavendish Hotel, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Enrol now | |
* Note the early booking discount cannot be combined with any other offers or promotional code
“It was overall a good course.”
Heetika Malik, QPPV, Interchemie werken "De Adelaar" B.V
“Excellent, well organised”
Nathalie Frontczak, QPPV, Boehringer Ingelheim
“Brilliant content and great speaker.”
Danny Wise, Administrative Officer, Veterinary Medicines Directorate
“An excellent course well presented”
David Collins, Veterinarian, David Collins
“The course was really useful, contained good information and moved at an appropriate pace. ”
Andrea Smith, Pharmacovigilance Team Leader, Boehringer Ingelheim Animal Health GmbH
“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
“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
“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
“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
“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
“Good.”
Elisa Ursich, Pharmacovigilance - VRO, Veterinary Medicines Directorate
“It is good course, covers major topics in PV. ”
Shahid Soomro, Head of Scientific Department , Bremer Pharma GmbH
“I think the course is presented in a brilliant manner and contains great informative content. ”
Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate
“Great speaker, very informative.”
Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate
“Knowledgeable presenter with a lot of experience, nice to have regulators amongst us. ”
Angela van der Salm, Director Pharmacovigilance, DADA Consultancy
“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.
“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.
“Interesting, engaging and very useful. I will be recommending it”
Caroline Mullen, Pharmacovigilance Officer, Boehringer Ingelheim
“Content – good. Presentation and speaker - good presenting and discussion over issues raised by delegates ”
Lynne Braidwood, Lead Monitor, Veterinary Clinical Studies, Triveritas