Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
This course aims to provide basic training for all those concerned with pharmacovigilance.
New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA and Japan.
Key topics to be addressed include:
Anybody involved and interested in the daily practice of pharmacovigilance, including pharmaceutical physicians and those working in:
Principles of pharmacovigilance and data resources
Risk management and risk minimisation: basic principles
Causality assessment: clinical diagnosis of adverse events
Discussion session
The current regulatory framework and its global impact
European post-marketing pharmacovigilance regulations
Overview of requirements which will include:
Proactive pharmacovigilance pre- and post-marketing
Discussion session
Risk-benefit assessment
Discussion session
Clinical trial ADR reporting requirements
Discussion session
Pharmacoepidemiological studies – basic designs, strengths, weaknesses and examples
Periodic reporting – PSURs and PBRERs
Discussion session
Drug surveillance in countries outside Europe
Practicalities of signal detection
Examples of pharmacoepidemiological studies used in risk management
Practicalities of risk management
A real-world example of the development of a successful EU risk management plan:
- Requirements of risk management plans from an industry point of view
- How to write a successful risk management plan
- Reporting results of outcomes of activities in the risk management plan
- Updating a risk management plan
Practical pharmacovigilance workshop
A practical case study with valuable hands-on experience:
- Handling an important safety alert from regulators
- Assessment of risk
- Determining measures to respond to previously unidentified risks
- Continuing assessment and communication of risk-benefit
| 22-24 Jun 2020 | |||
| 22-24 Jun 2020 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
| 7-9 Dec 2020 | |||
| 7-9 Dec 2020 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
“The course gave overall understanding on pharmacovigilance. The presentations were clear and with helpful examples. Interaction between participants and speakers was great. All the speakers have good experiences and knowledge.”
Teodora Crowe-Wijasa, Consultant Medical Safety Physician, DADA Consultancy BV
“Obviously all speakers have huge experiences within the PV processes. ”
Haiping Ma, Senior Safety Quality Professional, Novo Nordisk A/S
“Workshop is very good because you have to USE the knowledge you gain. Interaction between speaker and attendees is very good too!”
Anna Bøgelund Møller, Pharmacovigilance scientist, Larix
“Amazing speakers with a wealth of knowledge and experience.”
Dalal Abdulaziz, Regulatory Manager, Al Hafez Trading Est
“My overall opinion is very positive, I am not disappointed at all. Speakers did a very good job - being approachable, giving examples, sharing his/her professional experiences, etc. Very knowledgeable speakers with relevant experience.”
Vania Horta, Drug Safety & Information Officer , Wockhardt UK Limited
“Co-ordinators were great, material provided was concise and well presented. Time for breaks and lunches were spot on. Most of the speakers were excellent. I have 18 months experience in PV and I felt like the course was at my level. This course is not suitable for beginners. ”
Bhupesh Panchal, Drug Safety & Information Officer, Wockhardt UK Limited
“Expert presenters with engaging and thoughtful presentations that allow plenty of time for questions and discussion. All very knowledgeable and engaging.”
Sam Allen, Drug Safety Operations Medic, Mundipharma Research Ltd.
“Exactly what we need. Very good. ”
Gabriel Georgescu, Regulatory Affairs Manager, Ewopharma AG
“A greatly organised and informative course given by driven and well informed speakers.”
Willem van Lierop, Senior Drug Safety employee, ApotheekZorg
“The course was very useful and interesting to me personally ”
Darya Pospíšilová, Pharmacovigilance Project Manager, Arriello
“Enjoyed the course. Although quite intense in the number of topics, it was well organized and stuck only to the important things. Would recommend and am thinking about continuing to The advanced PV one.”
Marta Telebar, PV Project Specialist, Arriello s.r.o.
“All the speakers are knowledgable and have good experience ”
Negin Goudarz, Pharmacovigilance Associate , Emas Pharma Ltd
“Very nice and informative course, very satisfied ”
Birgitte Wolf, Senior Safety Specialist , LEO Pharma
“Found the content delivered from the speakers very good.”
Priya Cutts, Report Specialist, Procter and Gamble Technical Centres Ltd
“I was happy about the location, the presenters and the organizers for this course”
Abdullah Al Dawood, QPPV and Regulatory Affairs Supervisor , Apotex Saudi Arabia
“The course was well structured and covered all important aspects of PV. Everything was presented in clear presentations with helpful examples. Interactions between participants and speakers was easy and helpful.”
Birte Hofmann, Director Pharmacokinetics Expert, Bayer AG
“Well organised and the speakers were very knowledgeable”
Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International
“Overall I found the course to be very informative. Not only did I learn new information, but it helped me realise how much information I have picked up through my short time working in the industry and it reinforced this knowledge. I liked that there were a number of different speakers from different backgrounds who effectively cover different aspects of the topic in depth.”
Sarah Bruce, Pharmacovigilance Officer, Kyowa Kirin
“It was very good, I had a great time”
Camille Soulet, Vigilances Training Officer, Pierre Fabre
“High level training with great speakers, very good welcome and accommodation”
Camille Soulet, Vigilances Training Officer, Pierre Fabre
“I feel this course gives a good amount of information and is presented well. The speakers are very knowledgeable ”
Lee Rolfe, Actavis plc
“Very passionate speakers”
Sabrina Montante, Safety Scientist, GlaxoSmithKline
“I think the course and its content were very well run and I would be happy to attend another course by Management Forum”
Lee Rolfe, Actavis plc
“Excellent. Very good speakers and interactions.”
Susanne Mathias, Senior GCP Advisor Specialist, Novo Nordisk A/S
“Informative and well-organised but quite heavy going in parts”
Gemma Anthony, PV & Regulatory Administrator, Meda Pharma Ltd
“It was a comprehensive, professional course, well organized and beneficial”
Liron Weisman, Pharmacovigilance Compliance Associate, Teva Pharmaceuticals Industries Ltd
“Very nice course which provides good instruction into PV and overall picture of PV requirements/obligations”
Oresta Makaruha Stegic, FDF RA manager, xellia