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
By the end of this course, participants will gain:
- A clear understanding of global regulatory requirements for drug safety
- An overview of U.S., EU, and UK pharmacovigilance frameworks, including EU GVP modules and UK MHRA requirements
- Knowledge of the PV System Master File (PSMF) and its key components
- Best practices for quality oversight in drug safety systems
- A practical understanding of signal detection, validation, and management
- Insights into QPPV responsibilities in the EU and UK
- Hands-on learning with case discussions and knowledge quizzes
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
This course is ideal for professionals involved in drug development, safety, and compliance, including:
- Pharmacovigilance & Drug Safety Teams
- Regulatory Affairs Professionals
- Clinical Development & Research Staff
- Quality Assurance & Compliance Personnel
- Senior Management & Executives with legal responsibility for drug safety
Faculty Steve Jolley
Global Expert in Drug Safety & Pharmacovigilance
Mendham, New Jersey, United States
Steve Jolley is a leading subject matter expert in global drug safety compliance, pharmacovigilance, and signal detection, with over 37 years of industry experience. He has worked with more than 300 clients worldwide, including organizations across North America, Europe, Japan, India, China, the Middle East, and Africa.
A graduate of Cambridge University, England, with degrees in Mathematics and Computer Science, Steve is an Adjunct Professor at Rutgers University, where he helped develop the Master’s Degree in Drug Safety and Pharmacovigilance.
He is a featured speaker at FDA, EMA, and MHRA conferences and webinars, presenting on topics such as auditing, signal detection, and data mining. As a member of DIA’s training faculty, Steve teaches in the Clinical Safety and Pharmacovigilance Certificate Program and previously served as Chairman of DIA’s Clinical Safety and Pharmacovigilance Steering Committee for North America.
