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 course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.
KEY TOPICS TO BE COVERED
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
09.00 Registration and Coffee
09.30 Start of meeting
Due Diligence
Training for Drug Safety Reporting Duties
Audits and Expectations
Compliance and Drug Safety
The PV Master File and the DDPS
Interactive Exercise: Designing the Requirements for a Safety Department and Drug Safety
17.00 Close of day one
09.00 Start of day two
Product Safety Reviews – Purpose & Function
INTERACTIVE EXERCISE: Designing the Requirements for a Safety Review Group
Safety Reporting in Licensing Agreements
Developing Company Core Safety Information – CIOMS III
INTERACTIVE EXERCISE: Deciding whether New Safety Data presented from a Clinical Trial should be put into Core Safety Information
PSURs and the New Revisions in ICH E2C
17.00 Close of day two
09.00 Start of day three
The EU Clinical Trials Directive
Risk/Benefit Determinations
INTERACTIVE EXERCISE: Reviewing the Safety of a Product
Risk Management Plans (including new EU requirements 2012)
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.
16.30 Close of day three
Graeme Ladds (24-26 Sep 2018, 25-27 Mar 2019)
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.
| 24-26 Sep 2018 | |||
| 24-26 Sep 2018 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
| 25-27 Mar 2019 | |||
| 25-27 Mar 2019 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
| 25-27 Sep 2019 | |||
| 25-27 Sep 2019 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
“Content, presentation and speaker were just great.”
Wendy Kleijberg, QPPV, Baggerman Farma Consult
“Very good speaker ”
Nicolas Vauche, Drug Safety Officer, AnticipSante
“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
“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
“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.
“It covers a lot of subjects, it was a complete course regarding activities in Pharmacovigilance. Presentation and speakers were really clean. ”
Gwladys Becuwe, Durg Safety Officier Junior, Anticipsante
“Was great, will support my work ”
Anette Wolfmeyer, Deputy QPPV (Qualified Person for Pharmacovigilance), Bayer Animal Health GmbH
“Good content and put into real life context”
Tony Rigden, Head Of Regulatory & Pharmacovigilance, Chiesi UK LTD
“Excellent ”
Olga Orlova, PV Process Manager, Bayer, JSC
“Very interesting and interactive course. Good training material and a competent trainer”
Francesca Romana Borgia, PV QA Specialist & Auditor, Chiesi
“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
“Excellent ”
Mona Bjørkmo, Pharmacovigilance Scientist, GE Healthcare AS
“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
“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.
“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
“Trainer is excellent ”
Murugan Addepalli, Senior Research Scientist, Sun Pharmaceutical Industries Ltd
“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
“More examples would be very helpful.”
Jung Hyun Byun, PV Associate, Dong-A ST Co.,Ltd
“Really beneficial -Graeme is the best ”
Trine Allerslev, Senior Pharmacovigialnce Specialist, LEO Pharma