The EU's Pharmacovigilance and Drug Safety Regulations rank among the most stringent globally. Yet, the complexity of these regulations presents a formidable challenge to this industry. Statistics reveal that over 80% of pharmaceutical companies struggle to maintain compliance, with 65% highlighting the pressing need for specialized training and expertise to navigate these intricate and evolving demands effectively.
This certified program will give you an in-depth understanding of the EU’s Pharmacovigilance and Drug Safety Regulations that leaders need to address key practical challenges. You will gain insights into an extensive array of critical subjects, including a thorough examination of the EU pharmacovigilance legislation, adverse drug reaction reporting, signal detection and management, periodic safety update reports, Good Pharmacovigilance Practices (GVP) and pharmacovigilance inspections.
Throughout the program, you will be immersed in the technical requirements of the pharmacovigilance legislation, ensuring that they are adept in understanding and complying with adverse event reporting timelines, post-authorization safety studies (PASS), risk management planning, and quality control. You will acquire insights into the core principles of pharmacovigilance compliance and learn how to establish a resilient framework to ensure that their products conform to pertinent legislation. Additionally, this program touches upon the legal issues associated with drug safety, the role of the European Medicines Agency (EMA) and national competent authorities (NCAs), and the resolution of compliance-related disputes that may arise. This program will also explore the latest developments in pharmacovigilance, such as the use of real-world evidence and artificial intelligence in safety monitoring.
Upon successful completion of the program, you will attain the Certification in EU Pharmacovigilance and Drug Safety Compliance. This distinguished certification will enhance your professional profile by demonstrating your expertise and comprehensive knowledge of the critical requirements for ensuring compliance with pharmacovigilance regulations and upholding the highest standards of patient safety throughout the drug lifecycle in the EU. The industry-recognized certification is valid for life, serving as a testament to your commitment to excellence in pharmacovigilance and drug safety management.
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This program will entitle you:
Pricing & Registration- Experience 2 days of instructor-led live training and gain in-depth knowledge on navigating EU pharmacovigilance regulations, from adverse event reporting to maintaining regulatory compliance.
- Attain the industry-recognized Certification in EU Pharmacovigilance and Drug Safety Compliance. This certification will demonstrate your expertise in developing a comprehensive pharmacovigilance system, ensuring your organization adheres to the stringent drug safety regulations governing the EU.
- Gain insights from impactful case studies and best practices in developing and implementing effective safety monitoring strategies, ensuring drug safety, safeguarding public health, and maintaining regulatory compliance.
- For inquiries, chat with our Program Advisors at advisor@charteredcertifications.com or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
The EU's pharmacovigilance legislation is ranked among the world’s most stringent regulations globally. A recent survey by the European Federation of Pharmaceutical Industries and Associations (EFPIA) revealed that 75% of pharmaceutical companies find the complexity of these regulations a significant compliance challenge. In addition, the legislation imposes strict timelines, such as submitting serious ADR reports within tight deadlines, and a 2023 industry survey showed that 68% of companies struggle to consistently meet these rigorous time frames.
This certified program is designed to equip you with an in-depth and comprehensive understanding of EU Pharmacovigilance and Drug Safety Regulations, as well as the complex compliance requirements necessary for navigating the pharmaceutical industry. Participants will gain knowledge on a wide range of critical subjects, including a detailed examination of the EU regulatory framework, the core principles of pharmacovigilance, advanced risk management strategies, and sophisticated post-marketing surveillance methodologies. Participants will also explore the processes involved in adverse drug reaction (ADR) reporting, including the collection, assessment, and submission of safety data in accordance with EU guidelines.
Throughout the program, participants will engage deeply in the key aspects of pharmacovigilance compliance, learning to design and implement robust safety monitoring systems that meet EU regulatory requirements for medicinal products. This includes mastering the technical requirements for pharmacovigilance activities such as signal detection, the development of risk management plans (RMPs), and periodic safety update reports (PSURs). Additionally, the program will explore the intricacies of managing large pharmacovigilance data sets, employing advanced data analytics to detect safety signals, and crafting effective risk communication strategies to ensure transparent and timely information dissemination to stakeholders.
Using real world case studies and practical examples, participants will also delve into the role of pharmacovigilance inspections, audits, and the regulatory oversight mechanisms utilized by the European Medicines Agency (EMA) and national competent authorities (NCAs) to ensure ongoing compliance. You will gain practical experience through detailed case studies and exercises, learning to navigate the legal and ethical challenges in drug safety, including the complexities of liability and patient confidentiality in pharmacovigilance.
Upon successful completion of the program, you will attain the Certification in EU Pharmacovigilance and Drug Safety Compliance. This distinguished certification will enhance your professional profile by demonstrating your expertise and comprehensive knowledge of the critical requirements for ensuring compliance with pharmacovigilance regulations and upholding the highest standards of patient safety throughout the drug lifecycle in the EU. The industry-recognized certification is valid for life, serving as a testament to your commitment to excellence in pharmacovigilance and drug safety management.
Key Skills You Will Gain
- Pharmacovigilance Regulatory Frameworks
- Adverse Drug Reaction (ADR) Reporting
- Adverse Event Classification
- Signal Detection and Analysis
- Risk Management Plan (RMP) Development
- Good Pharmacovigilance Practices (GVP) Implementation
- EudraVigilance Database Management
- Safety Signal Prioritization and Assessment
- Post-Authorization Safety Study (PASS) Design
- Pharmacovigilance System Master File (PSMF) Maintenance
- EMA Guidelines Compliance
- Regulatory Deadline Management
- Audit and Inspection Preparation
- Health Authority Engagement Strategies
- Benefit-Risk Evaluation
- Regulatory Intelligence and Monitoring
- Data Quality Assurance in Safety Reporting
- Emerging Technologies in Drug Safety
- Periodic Safety Update Report (PSUR) Preparation
- Pharmacovigilance Reporting
- Effective Communication of Safety Information
- Medication Error Prevention and Reporting
- Regulatory Documentation Management
- Inspection Preparation
- AI in Safety Monitoring
- Safety Monitoring System Design
- Pharmacovigilance Compliance
Your Faculty Director
Dr. Irene Michas is a seasoned professional in the field of pharmacovigilance with more than twenty years of experience in the pharmaceutical industry. She served as Regional Safety Manager-Senior Director for the Asia, Africa and Middle East region at Pfizer Research and Development UK where she managed and implemented new business initiatives and updates to procedures and systems. She has led working groups for the development and global implementation of numerous initiatives to facilitate compliance with pharmacovigilance requirements.
Dr. Michas’ expertise also extends to the development of comprehensive training programs to support the global rollout of new pharmacovigilance systems (e.g., Argus, ARISg), and in leveraging advanced technology for the development of e-learning programs. Her in-depth knowledge of international pharmaceutical product regulations and extensive experience in various aspects of drug development activities make her an exceptionally qualified professional in the field of pharmacovigilance.
Dr. Irene Michas is a Phi Beta Kappa scholar with a Bachelor of Arts degree in the field of Biological Basis of Behaviour from the University of Pennsylvania, USA, as well as an MSc and PhD in Psychology (Developmental, Cognitive, Experimental) from Reading University, UK.
EU Pharmacovigilance and Drug Safety Regulations and Compliance Program Agenda
How You Will Benefit
- Develop Advanced Skills in EU Pharmacovigilance: Understand the full spectrum of EU pharmacovigilance regulations, including the roles of key regulatory bodies like the EMA.
- Enhance Compliance Skills: Learn to implement Good Pharmacovigilance Practices (GVP) and ensure compliance with stringent EU drug safety standards.
- Master Adverse Event Reporting: Acquire the skills to manage adverse drug reactions (ADRs) and use EudraVigilance effectively for safety data reporting.
- Improve Signal Detection Abilities: Develop proficiency in identifying, analyzing, and prioritizing safety signals to enhance public health outcomes.
- Develop Robust Risk Management Plans (RMPs): Learn to create, implement, and monitor effective RMPs to mitigate risks associated with pharmaceutical products.
- Prepare for Inspections and Audits: Gain insights into preparing for pharmacovigilance inspections and audits, improving your readiness and compliance.
- Leverage Advanced Technologies: Understand how to utilize emerging technologies, such as AI and machine learning, for efficient pharmacovigilance processes.
- Build Effective Communication Strategies: Learn to develop and implement strategies for engaging with regulatory authorities and communicating safety information effectively.
- Stay Ahead of Regulatory Changes: Stay informed on future trends and evolving global pharmacovigilance regulations to adapt proactively.
- Strengthen Global Pharmacovigilance Operations: Enhance your ability to lead and manage global pharmacovigilance systems, ensuring consistent compliance and safety across all markets.
Certification in EU Pharmacovigilance and Drug Safety Compliance
Upon successfully attending this program, you will be awarded with the Certification in EU Pharmacovigilance and Drug Safety Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally recognized and highly sought after, this certification will elevate your professional credentials and demonstrate your expertise in navigating the complex landscape of EU pharmacovigilance regulations. It will also validate your ability to implement a comprehensive compliance framework, ensuring your organization's drug safety practices align with the rigorous standards of the EU. Developed by the Chartered Institute of Professional Certifications, this program's content has been independently accredited by the CPD Certification Service, adhering to the highest standards of continuing professional development principles.
Pricing & Registration
Europe
Dates: 26 - 27 Mar 2025
Venue: Online Executive Program (via Zoom)
Time: 10:00am - 5:30pm Central European Time (CET)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 21 Jan 2025 | By 04 Mar 2025 | After 04 Mar 2025 | |
| EU Delegates | EUR 1,295 | EUR 1,495 | EUR 1,595 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
Securing approval from your boss to attend this program can be difficult if you don’t know what to say. So, we’ve prepared a template for you! All you need to do is to download this template, copy and paste in email and send it to your boss!
EU Pharmacovigilance and Drug Safety Regulations and Compliance
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