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
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:
Benefits of attending:
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.
Due Diligence
Training for drug safety reporting duties
Audits and expectations
Compliance and drug safety
The PV system master file (PSMF)
Interactive exercise: The requirements for a safety department
Product safety reviews – purpose and function
Interactive exercise: Designing the requirements for a safety review group
Safety reporting in licensing agreements
Developing company core safety information (CCSI) – CIOMS III
Interactive exercise: Should new safety data from a clinical trial be put into core safety information?
PSURs and the revisions in ICH E2C
The EU Clinical Trials Directive
Risk-benefit determinations
Interactive exercise: Reviewing the safety and risk/benefit of a product
Risk Management Plans (RMP)
Crisis management within drug safety
Interactive exercise: Deciding how to handle a major crisis within the company
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
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.
| 25-27 Sep 2019 | |||
| 25-27 Sep 2019 | Radisson Blu Edwardian Vanderbilt, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now Limited places |
| 25-27 Mar 2020 | |||
| 25-27 Mar 2020 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
| 23-25 Sep 2020 | |||
| 23-25 Sep 2020 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
“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 3 days, I really enjoyed this course.”
Ciara Walsh, Head of Regulatory Affairs and Pharmacovigilance, Noden Pharma DAC
“Very valuable with real examples. I liked that future elements of PV regulation was pointed out and not just the current one”
Dorthe Lundmark, Drug Safety Coordinator, Pharmacosmos A/S
“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, Pharmacovigilance and Medical Information Manager, Blue Earth Diagnostics
“[The speaker} Shared a lot of knowledge and experiences which put in context the regulation/expectations from agencies, and makes the course really interesting.”
Audrey Dicaire-Lavigne, Pharmacovigilance Leader, Jubilant Draximage Inc.
“Great presentations, great time keeping, good balance between exercises and presentations”
Ida Mizera, Local Responsible Person for PV, Grunenthal Ltd
“The speaker had a really extensive knowledge and he was able to transmit in a very clear way all the topics. ”
Elena Jiménez Gutiérrez, Global Safety Professional, LEO Pharma
“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
“A very knowledgeable and experienced speaker always ready to answer all the questions and give real-life examples.”
Darya Pospíšilová, Pharmacovigilance Project Manager, Arriello
“A PV overview in three days, that's nice.”
Tina Pank Vase, Associate Professional, LEO Pharma A/S
“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
“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
“I have understood better from where some regulations come from(Cions). Graeme is a great lecturer who managed to keep the 3 days always dynamic and live ”
Faouria Dervisagic, Drug Safety Associate, Idorsia Pharmaceuticals Ltd
“Was great, will support my work ”
Anette Wolfmeyer, Deputy QPPV (Qualified Person for Pharmacovigilance), Bayer Animal Health GmbH
“Very good speaker ”
Nicolas Vauche, Drug Safety Officer, AnticipSante
“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
“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.
“Content, presentation and speaker were just great.”
Wendy Kleijberg, QPPV, Baggerman Farma Consult
“Excellent ”
Olga Orlova, PV Process Manager, Bayer, JSC
“Good content and put into real life context”
Tony Rigden, Head Of Regulatory & Pharmacovigilance, Chiesi UK LTD
“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
“Very interesting and interactive course. Good training material and a competent trainer”
Francesca Romana Borgia, PV QA Specialist & Auditor, Chiesi
“Very experienced in many areas relevant for PV. Good examples. Open for questions and discussions. ”
Ingvild Haugen, PV Scientist, GE Healthcare
“Very good (advanced) course”
Peter Kohut, PV Specialist, Ewopharma International, s.r.o.
“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
“Excellent ”
Mona Bjørkmo, Pharmacovigilance Scientist, GE Healthcare AS
“Trainer is excellent ”
Murugan Addepalli, Senior Research Scientist, Sun Pharmaceutical Industries Ltd
“Really beneficial -Graeme is the best ”
Trine Allerslev, Senior Pharmacovigialnce Specialist, LEO Pharma
“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
“I am really happy with all of it ”
Jelena Rebernisak, TPC Operations Coordinator, Pliva Croatia Ltd.
“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
“More examples would be very helpful.”
Jung Hyun Byun, PV Associate, Dong-A ST Co.,Ltd