Presented by
Management Forum
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
★★★★★ "Learned a lot! The presenter was definitely a subject matter expert who was able to answer my questi... more (64)"
9-13 December 2024
+ 24-26 March 2025, 2-4 July 2025, 6-10 October 2025 »
from £1599
Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform. This three-day course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.
Key topics to be addressed:
This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.
This course would be of maximum benefit to those safety professionals who are working both in the clinical and post–marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.
Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
9-13 December 2024
Live online
13:00-17:15 UK (London) (UTC+00)
14:00-18:15 Paris (UTC+01)
08:00-12:15 New York (UTC-05)
Course code 14096
Not ready to book yet?
for 7 days, no obligation
24-26 March 2025
Live online
09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
05:00-12:30 New York (UTC-04)
Course code 14605
Until 17 Feb
Not ready to book yet?
for 7 days, no obligation
2-4 July 2025
Classroom
Rembrandt Hotel
London
09:00-17:00 UK (London)
Course code 14724
Optional £300/€419/$479 per night
Until 28 May
Not ready to book yet?
for 7 days, no obligation
6-10 October 2025
Live online
13:00-17:15 UK (London) (UTC+01)
14:00-18:15 Paris (UTC+02)
08:00-12:15 New York (UTC-04)
Course code 15137
Until 01 Sep
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Learned a lot! The presenter was definitely a subject matter expert who was able to answer my questions immediately. He didn't just read from the slides and was able to provide examples of concepts using real-life experience. I found the sections on the PSMF and Benefit vs. Risk particular helpful.
Sep 18 2024
Scott Aveni
Corp R&D QA, PV US Compliance Mgr., Chiesi USA
Sep 18 2024
The speaker demonstrated a deep understanding of pharmacovigilance and regulatory processes, providing valuable insights into the complexities of signal detection and risk management [with] real-world examples and case studies that were directly applicable to my work in drug safety and pharmacovigilance.
Intan Soleha
Senior Executive, PHARMANIAGA BERHAD
Sep 18 2024
The speaker demonstrated a deep understanding of pharmacovigilance and regulatory processes, providing valuable insights into the complexities of signal detection and risk management.
Intan Soleha
Senior Executive, PHARMANIAGA BERHAD
Dec 11 2023
Yes the trainer was very good! I think that we have received a lot of new information.
Styliani Katsarou
Quality Consultant, Scandinavian Regulatory Services
Sep 20 2023
Practical knowledge of situations in Industry and the slides contained enough information to obtain a good understanding of an area that is complicated. the webinar was excellent, the speaker was very familiar with the most recent legislation
Martina Lee
Regulatory Affairs Specialist, NorthStar
Sep 20 2023
I really enjoyed the course and took a lot out of it. The real life examples were really helpful.
Joana Pereira
Senior RA Manager, Cycle Pharmaceuticals Ltd
Jun 7 2023
In my overall opinion, the course was excellent in terms of content, organisation and presentation. The content was well-structured, comprehensive, and covered relevant topics that were of interest to me. The material was presented in a clear and organised manner, making it easy to follow and understand. I would highly recommend this course to others seeking to gain knowledge in the subject matter.
Mareike Vogt
Senior Associate Patient Safety & Consumer Service, Omega Pharma Deutschland GmbH
Jun 7 2023
great course
Omar H. AlAnazi
Control and Alarm Specialist 2 - Pharmacovigilance, Saudi Food & Drug Authority
Jun 7 2023
Excellent speaker. I do really respect his knowledge
Abdulaziz N Alakeel
Alert and Controling Specialist I, Saudi Food & Drugs Authority
Mar 22 2023
Very lively presentation, not at all a dull workshop. I Will recommend it as it was very good
Bettina Bannert
Doctor, Universitätsspital Basel/ Department Klinische Forschung
Mar 22 2023
Very wide topic, yet concise and understandable
Marko Laginja
PV deputy, Providens d.o.o.
Sep 20 2023
Was so good
Hammad A Al Dali
Expert in Pharmacovigilance System Inspection, Saudi Food & Drugs Authority
Mar 22 2023
Very satisfied with the material provided, manner of delivery and content discussed.
Matthew Zarb
Pharmacovigilance Scientist & Responsible Person , Eugia Pharma (Malta) Ltd
Mar 1 2022
This course is one of the best Pharmacovigilance course where you can discuss the complex issues, speaker has strong PV background and tremendous knowledge... Course is just perfect.
Sagar Lamichhane
Sr. Pharmacovigilance Specialist, GE Healthcare
Mar 1 2022
I really enjoyed the webinar, very informative and the speaker was very knowledgeable and put you at ease. I feel more confident in my role.
Shelley Browning
Regulatory and PV Manager, Weleda
Mar 1 2022
Fantastic speaker! Well-paced, informative, stayed on schedule, answered questions, provided valuable anecdotes from his experiences. I learned and absorbed MUCH more in this webinar than for ex. the Intro. Pharmacovigilance that was in person with multiple speakers.
Sarah Yandura
Global Safety Specialist, LEO PHARMA
Mar 1 2022
Fantastic - I would recommend this course to all in this field of work.
Jenny Hipwell
Pharmacovigilance Manager, MSD Animal Health UK Ltd
Sep 21 2022
I was hoping to broadening my PV knowledge in the human area and to be able to compare with my knowledge in veterinary PV. I thought the subjects were perfect and lever also good (not too easy).
Sarah Bodeby
Pharmacovigilance Specialist, PharmaRelations AB
Sep 21 2022
He (Graeme Ladds) is a very experienced professional and his practical examples of inspections' findings in companies were really useful to understand what the main faults are.
Maria Sampaio
Associate Pharmacovigilance and Drug Safety Manager, BIAL - Portela & Cª, S.A.
Dec 1 2021
It was very informative and really useful training for PV professionals
Viranchi Desai
Senior Manager , Gilead Science
Dec 1 2021
Graeme was really excellent, although a lot of slides he managed to keep me focused for all those hours with his stories from interactions with CA and MAH. So interesting. That is what you need, examples from the real world. The interactive sessions were also much appreciated. I feel that I got it all! However, another course with Graeme is now on my list.
Åsa Kjellström
Pharmacovigilance Senior Safety Scientist, Calliditas Therapeutics AB
Mar 17 2021
Really good speaker, lots of examples of scenarios which helps. Allowed interaction between the delegates to discuss topics during exercises.
Rebecca Brennan
Safety Advisor, Alliance Healthcare Ltd
Mar 17 2021
Inspiring speaker. I was very excited about all the anecdotes that he told. Overall a very rewarding course.
Helle Ribjerg
Safety Scientist, Genmab
Mar 17 2021
Very good webinar. Well structured, interactive questions, small group, advanced topics (not easy to find elsewhere), competent speaker, good platform.
Bettina Isler
Medical Information Manager, OrPha Swiss GmbH
Sep 23 2020
Great
Sidse Schjøtz
Complinace Manager, ALK
Sep 23 2020
Very nice course - will recommend to colleagues
Tina Rishoej Clausen
Global Safety Specialist, LEO Pharma
Sep 23 2020
Good course and the leader was very clear in what he wanted to say. Exercises were fun..
Amrita Kang
drug safety scientist, GE healthcare
Sep 23 2020
Generally very good and good to have the anecdotes from real life.
Sanne Mathias
Head of Compliance, ALK
Sep 23 2020
Parts of the presentation especially Day 3 were informative as it was more tailored to my role. I enjoyed the talk of RMPs, PSURs and crisis management. A lot of basics however were covered in this 'advanced course' in the CT directive topic, would be nice just to state what's changed and what's not changed almost like presenting a gap analysis, instead of covering basic definitions such as definition of an SAE and SUSAR and investigator reporting timelines. There was a 2 minute discussion on Brexit related changes on Day 2 which could have been a formal session as a presentation as I found that very useful for my role.
Maria Sajid
Safety Evaluation Scientist, Eisai Europe Ltd
Sep 25 2019
Overall, the best seminar I've attended in format, topics, and speaker. I had hoped to learn about PV in general and all the different reporting requirements and report types – I learned much more than that. The speaker was great and I particularly liked the real-life stories and examples.
Jane Bateman
Senior Drug Safety Scientist, GE Healthcare
Sep 25 2019
I was hoping to get more knowledge about the topics listed in the course presentation and I actually got a lot more, as we were not only given information related to the legislation in force but also very useful examples of applicability and some non-compliance cases. The speaker is undoubtedly an expert in the field with excellent presentation skills of all the proposed topics, including the most complex ones from a regulatory point of view. His experience and his analytic method facilitated my understanding of some critical passages of the law.
Ilaria Gargano
Global Safety Specialist, Leo Pharma
Mar 25 2019
The speaker shared a lot of knowledge and experiences which put in context the regulation/expectations from agencies and made the course really interesting.
Audrey Dicaire-Lavigne
Pharmacovigilance Leader, Jubilant Draximage Inc.
Mar 25 2019
The speaker had really extensive knowledge and he was able to transmit all the topics in a very clear way.
Elena Jiménez Gutiérrez
Global Safety Professional, LEO Pharma
Mar 25 2019
Great presentations, great time keeping, good balance between exercises and presentations
Ida Mizera
Local Responsible Person for PV, Grunenthal Ltd
Mar 25 2019
Graeme has superb knowledge of the regulations and guidelines around pharmacovigilance and talks in a passionate and engaging manner. An excellent course that really gives the students a much better understanding of pharmacovigilance and the opportunity to share knowledge. The content was spot on and Graeme's presentation style was engaging.
Christopher Harper
Senior Medical Information Manager, Astellas Pharmaceuticals
Sep 25 2019
The speaker was able to make a dry topic really exciting and I particularly liked the interaction with the group.
Margot Börgartz
Stewardship Manager, Bayer AG
Sep 25 2019
[Graeme] was a very good presenter with very good industry knowledge and experience. Very interactive sessions and answered all our questions.
Smitha Bhat
Principal CMG Scientist, GlaxoSmithKline
Mar 25 2019
Very valuable with real examples. I liked that future elements of PV regulation were pointed out and not just the current one.
Dorthe Lundmark
Drug Safety Coordinator, Pharmacosmos A/S
Mar 25 2019
The content of the course was excellent for an all round view of PV, the presentations were good and flowed from one aspect of PV to another. Graeme's passion and energy for drug safety was evident throughout the three days. I really enjoyed this course.
Ciara Walsh
Head of Regulatory Affairs and Pharmacovigilance, Noden Pharma DAC
Mar 7 2018
Amazing for continuing to develop skills in PV to keep up with the regulatory expectations.
Maria Calvo Subirats
GCP&GVP Responsible (QA Unit), Ferrer Internacional
Mar 7 2018
The presenter managed to keep our attention and shared concrete examples, which helped us to clearly understand what's relevant.
Faouria Dervisagic
Drug Safety Associate, Idorsia Pharmaceuticals Ltd
Mar 7 2018
Was great, will support my work
Anette Wolfmeyer
Deputy QPPV (Qualified Person for Pharmacovigilance), Bayer Animal Health GmbH
Mar 7 2018
Excellent course - taught me from A to Z about PV. Content well coordinated to capture audience with different levels of PV experience. Excellent speaker. Highly recommended.
Suna Horner
Associate Medical Manager, HRA Pharma UK & IE Ltd.
Mar 7 2018
Very good speaker
Nicolas Vauche
Drug Safety Officer, AnticipSante
Mar 7 2018
This course provides a great opportunity to gain understanding of latest updated on the PV regulatory requirements and the expectation from regulatory inspectorate.
Maria Calvo Subirats
GCP&GVP Responsible (QA Unit), Ferrer Internacional
Sep 24 2018
A very knowledgeable and experienced speaker always ready to answer all the questions and give real-life examples.
Darya Pospíšilová
Pharmacovigilance Project Manager, Arriello
Sep 24 2018
The course was thorough and the manual a good resource to refer back to. The speaker had a very engaging presentation style and freely answered questions and shared real-word examples and inspection expectations.
Katy Blake
PV Specialist , Dexcel Pharma Limited
Sep 24 2018
A PV overview in three days, that's nice.
Tina Pank Vase
Associate Professional, LEO Pharma A/S
Mar 7 2018
Content, presentation and speaker were just great.
Wendy Kleijberg
QPPV, Baggerman Farma Consult
Mar 7 2018
It covers a lot of subjects, it was a complete course regarding activities in Pharmacovigilance. Presentation and speakers were really clean.
Gwladys Becuwe
Drug Safety Officer, Anticipsante
Sep 25 2017
Excellent
Olga Orlova
PV Process Manager, Bayer, JSC
Sep 25 2017
Good content and put into real life context
Tony Rigden
Head Of Regulatory & Pharmacovigilance, Chiesi UK LTD
Sep 25 2017
Very interesting and interactive course. Good training material and a competent trainer
Francesca Romana Borgia
PV QA Specialist & Auditor, Chiesi
Sep 25 2017
Graeme is clearly a PV Expert. The content of training gave a very good overview of all aspects of PV. Finally, a course that you can use in your daily work-life.
Thea Ellermann Petersen
Senior Pharmacovigilance Specialist, LEO Pharma
Mar 6 2017
Excellent
Mona Bjørkmo
Pharmacovigilance Scientist, GE Healthcare AS
Mar 6 2017
Very good (advanced) course
Peter Kohut
PV Specialist, Ewopharma International, s.r.o.
Mar 6 2017
Very experienced in many areas relevant for PV. Good examples. Open for questions and discussions.
Ingvild Haugen
PV Scientist, GE Healthcare
Mar 6 2017
Very good speaker with a wealth of knowledge. Good examples and real life stories. Would like other activities rather than pure listening.
Lisa Courtier
Drug Safety Officer, JensonR+ Limited
Sep 28 2016
Trainer is excellent
Murugan Addepalli
Senior Research Scientist, Sun Pharmaceutical Industries Ltd
Sep 28 2016
Content - highly relevant to my position. Presentation - enough detail and to the point. Speaker - very knowledgeable and engaging
Saha Jasarevic
Global Pharmacovigilance Scientist, GE Healthcare AS
Sep 28 2016
Overall a very positive experience, the course covers very current and relevant topics, is well organised and presenter is an engaging speaker
Rita Bildøy
PV Compliance and Training Expert, Ge Healthcare Lifesciences
Sep 28 2016
Really beneficial -Graeme is the best
Trine Allerslev
Senior Pharmacovigialnce Specialist, LEO Pharma
Sep 28 2016
I am really happy with all of it
Jelena Rebernisak
TPC Operations Coordinator, Pliva Croatia Ltd.
Sep 28 2016
More examples would be very helpful.
Jung Hyun Byun
PV Associate, Dong-A ST Co.,Ltd
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3 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: