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.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Download Brochure Pricing & RegistrationThis 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.
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.
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.
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.
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 NowYou can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at [email protected] or call us at:
Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
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EU Pharmacovigilance and Drug Safety Regulations and Compliance
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