Training Overview
Product safety makes headlines every day -- and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. Are you confident your current pharmacovigilance operations will meet the latest US, EU and UK expectations for compliance and keep your products on the market? Do you understand the processes needed to perform adequate risk assessment?
Not knowing which systems and processes you must have in place for your own safety reporting could mean you miss an important issue with significant consequences for your product. You must be sure you have the understanding you need to avoid product recall, are able to work to international standards and have implemented regulatory requirements for signaling and risk management.
This training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to product safety regulatory requirements. The course will illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
What You'll Learn
- An understanding of regulatory requirements for drug safety
- Overview of US, EU and UK regulatory framework, including details of EU GVP modules and additional requirements for the UK
- Contents of the PV System Master File (PSMF)
- Requirements for quality oversight of drug safety
- Regulations for signal management
- EU and UK QPPV requirements and responsibilities
- An engaging and experienced instructor
- Multiple choice quizzes to test your understanding of the course
Agenda
Global Regulatory Requirements
- Legalities – US
- Legalities – EU
- Penalties for Non-Compliance
- Matrix of Safety Regulations
- FDA Regulations
- FDA Regulation for IND safety reporting
- IND Annual Report
- Literature Reporting
- International Conference on Harmonisation (ICH)
- ICH Topic Codes and Reports
- CIOMS
- Canadian Regulations
- Key EU Components
- EU Member States
- What is Europe? EU, EEA, EFTA
- Eudravigilance – Pre-Marketing Requirements
- Eudravigilance – Post-Marketing Requirements
- EUDRACT
- EU Clinical Trial Directive
- EU Clinical Trials Regulation
- CTIS
- Qualified Person for Pharmacovigilance (QPPV) requirements
- Development Safety Update Report
- European Signaling Regulations
· EU Pharmacovigilance Legislation
- Summary of Requirements
- Penalties and fees
- GVP modules
- Quality systems
- Audit and inspection
- PV System Master File (PSMF)
o ADR reporting
- EU and ex-EU Requirements
- Internet and Social Media
- Post-Authorisation Studies
- Biologics
o Periodic Safety Update Reports
- Periodic Benefit-Risk Evaluation Report
- PSUR Periodicity, ex-EU
- PSUR Periodicity, EU
- PSUR (PBRER) New Features
- PSUR Sections: Detailed Requirements
o Signal management
- MAH Responsibilities
- Signal Detection
- Signal Validation
- EudraVigilance Monitoring
- EudraVigilance Pilot Program
o UK Regulatory Requirements
- UK QPPV
· Quiz Questions
Who Will Benefit
Almost everyone involved in drug development and marketing needs to know the basics of worldwide regulations regarding drug safety. Staff who will benefit include:
- Drug safety and pharmacovigilance
- Regulatory affairs
- Clinical development
- Executives (including C-Level) with any legal responsibility for drug safety
Faculty Steve Jolley
Drug Safety and Pharmacovigilance Consulting: Auditing, Signaling, Training
Mendham, New Jersey, United States
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection.
Steve has 37 years’ experience in drug safety & pharmacovigilance and has worked with 300 clients in North America, Europe, Japan, India, China, the Middle East, and Africa. He holds degrees in mathematics and computer science from Cambridge University, England. He is an Adjunct Professor at Rutgers University and developed part of their Master's degree in Drug Safety and Pharmacovigilance.
Steve is a featured speaker with FDA, EMA and MHRA at conferences and webinars on auditing, signaling and data mining. He is a member of DIA’s training faculty and is an instructor for DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In 2010 Steve was elected as chairman of the DIA’s Clinical Safety and Pharmacovigilance steering committee for North America.
