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Management Forum

Advanced Pharmacovigilance Training Course

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.

18-20 September 2024
+ 9-13 December 2024 »
from £1349

Need help? Enrol or reserve

Format: Live online
CPD: 18 hours for your records
Certificate of completion

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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)

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.

Benefits of attending

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.

Enrol or reserve

The Advanced Pharmacovigilance course will cover:

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

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

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.

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Graeme Ladds
PharSafer Associates Ltd

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

18-20 September 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13888

GBP 1,349 1,649
EUR 1,939 2,359
USD 2,201 2,669

Until 14 Aug

3 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

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

GBP 1,349 1,649
EUR 1,939 2,359
USD 2,201 2,669

Until 04 Nov

5 sessions of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

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.