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Advanced Pharmacovigilance
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.
Course overview
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:
- Audits and expectations – risk-based inspections
- Compliance and drug safety
- Overview of the PSMF in the EU
- Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
- Safety reporting in licensing agreements
- Developing company core safety information (CCSI) – CIOMS III
- PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
- Implications for safety reporting in global clinical trials
- Risk-benefit determinations
- Risk management plans (RMPs)
By attending this event, you will:
- Expand your global safety knowledge
- Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
- Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
- Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections
Who should attend?
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.
Programme – day one
Due diligence
- Due diligence on products/companies (partners and acquisitions)
- Due diligence involvement – team composition
- Safety information requirements for due diligence
- Review of safety data (clinical and post-marketing)
- Defining risk in due diligence appraisals
Training for drug safety reporting duties
- Regulations concerning safety training
- Who trains whom and when?
- Training versus job description
- Training records, maintenance and updates
- Role of QA and HR in training
Audits and expectations
- Regulatory expectations in pharmacovigilance audits (risk-based inspections)
- Preparation for the audit
- Records to be available at the audit
- Audit findings/recommendations
Compliance and drug safety
- Basic principles – what will the regulators want to see?
- Measuring compliance
- Quality versus quantity in safety reports
- Future aspects in ensuring efficient compliance
- Quality management under the new EU legislation
The PSMF
- The PSMF – purpose and maintenance
- The PSMF annexes
- The PSMF and audits
Interactive exercise: The requirements for a safety department
Programme – day two
Product safety reviews – purpose and function
- The Safety Review Committee (SRC)
- What to look for in signal evaluation under latest EU guidance
- Timings for safety review in clinical and post-marketed products
- Record keeping for safety review meetings
- Serious safety findings – crisis management following new safety findings
Interactive exercise: Designing the requirements for a safety review group
Safety reporting in licensing agreements
- What types of licensing agreements exist?
- What are the EU and FDA regulations concerning licensing agreements?
- Audits of pharmacovigilance capabilities in licensing partners
- What agreements need to be in place for safety reporting?
- Safety reporting agreements – what needs to be covered?
- Monitoring safety agreements – what happens if it goes wrong?
Developing CCSI – CIOMS III
- CIOMS III and CCSI
- Developmental core safety information (DCSI)
- How to determine what to include and what to exclude in DCSI/CCSI
- Are there differences in EU and FDA?
- Maintenance and development of CCSI
Interactive exercise: Should new safety data from a clinical trial be put into core safety information?
PSURs and the revisions in ICH E2C
- Timing for PSURs
- PSUR content and latest format
- Late breaking information and PSUR extensions
- The DSUR
Programme – day three
The EU Clinical Trials Directive
- The principles of the Directive
- Implications for safety reporting in global clinical trials
- The SUSAR database
- The EUDRACT database
- The new EU Clinical Trial Regulation
Risk-benefit determinations
- Definitions of risk-benefit – FDA and EU perspective
- Risk-benefit assessments – who does this and where does the information go?
- Safety assessments and risk-benefit – frequency and reporting
- Changes in risk-benefit – how to manage and review existing profiles
Interactive exercise: Reviewing the safety and risk-benefit of a product
RMPs
- Purpose
- Content
- Monitoring and updating the RMP
- Reporting the RMP
Crisis management within drug safety
- Regulations and guidelines in connection with serious safety issues
- What determines a crisis?
- Communications to regulators – what is required?
- Communications within the company
- What happens next?
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.
Presenter
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.
Book 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 Limited places |
| 17-19 Mar 2021 | |||
| 17-19 Mar 2021 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
| 23-25 Sep 2021 | |||
| 23-25 Sep 2021 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
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Previous customers include...
- Amgros
- Astellas Pharma
- Baxter Innovations GmbH
- BAYER AG
- Blue Earth Diagnostics
- Forest Laboratories UK Ltd
- GE Healthcare
- Glaxo Smithkline Biologicals
- GW Pharmaceuticals
- Icon Clinical Research (UK) Limited
- Innovata Ltd (part of Vectura Group plc)
- Janssen-Cilag Ltd
- Kamada Ltd.
- Laboratorios Almirall S A
- Medica SA
- Merck Sharp & Dohme
- mundipharma ksa
- N V Organon
- Napp Pharmaceutical Group Ltd
- NeuroDerm
- Prime Vigilance doo Zagreb
- Research and Markets
- Sanofi-aventis AB
- Sanofi-Aventis SA
- SEQ Limited
- Shandon McGee Pharmacovigilance Company
- SHIRE CANADA
- SPEEDEL PHARMA LIMITED
- Statens Serum Institut
- UCB Pharma SA
“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 19
“[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, Sep 19
“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 19
“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, Sep 19
“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, Mar 19
“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 19
“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 19
“Great presentations, great time keeping, good balance between exercises and presentations”
Ida Mizera, Local Responsible Person for PV, Grunenthal Ltd, Mar 19
“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 19
“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 19
“A PV overview in three days, that's nice.”
Tina Pank Vase, Associate Professional, LEO Pharma A/S, Sep 18
“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 18
“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 18
“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 18
“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 18