Pharmacovigilance for Clinical, Regulatory, and QA Professionals 

Pharmacovigilance is an essential component of drug development and regulatory processes. It involves the collection, evaluation, and monitoring of information related to the safety of medicinal products. The importance of pharmacovigilance has increased significantly in recent years, and regulatory authorities require pharmaceutical companies to have comprehensive pharmacovigilance systems in place to ensure patient safety.   

 Pharmacovigilance for Clinical, Regulatory, and QA professionals course is designed for participants who collaborate with pharmacovigilance staff in their daily work.  This may include participants from QA, pre-clinical, clinical, regulatory, commercial, legal, IT or medical affairs who have little to none experience or knowledge of pharmacovigilance.  

The course will provide an in-depth overview of the role of safety and pharmacovigilance throughout the product lifecycle, from pre-clinical studies to clinical studies and all the way to post-marketing including post-marketing studies. The course will focus on  the rules and regulations set by the European Union (EU).  

Participants will gain a solid understanding of the history of pharmacovigilance, the importance of pharmacovigilance in the pharmaceutical industry, the definition of an adverse event, sources of adverse event reports, evaluation and assessment of adverse event reports, and quality requirements within the pharmacovigilance area.  

Pharma IT Academy uses innovative teaching methods, including a case handling exercise that provides hands-on experience in evaluating an adverse event report. The course also includes interactive lectures and discussions to facilitate learning and engagement.   

Additionally, the course material is presented in an easy-to-understand format that is accessible to all participants.   

About Instructors 

Louise Søgaard Nielsen is a principal Consultant with more than 20 years of experience from the pharmaceutical industry. Experienced with working in headquarters with all aspects of pharmacovigilance including; Individual Case Safety Reports (ICSR) processing, authoring aggregated safety reports such as PSUR/PBRER and DSUR; performing Signal detection, maintaining and building quality management systems; performing pharmacovigilance training, building and updating the Pharmacovigilance System Master File, writing and maintaining all types of Pharmacovigilance contracts, participating in various Pharmacovigilance audits and inspections, vendor selection and approval, risk assessment and conducting pharmacovigilance audits.

Mie Sørensen is a Pharmacovigilance Consultant with over 10 years of experience in the pharmaceutical industry, covering the entire drug lifecycle from clinical trials to post-marketing surveillance. Expertise includes case processing, medical review and assessment, company comment preparation, health hazard evaluations, signal detection, and the development of aggregate reports such as DSURs and PSURs. Experience spans roles at both affiliate and headquarters levels, combining a deep understanding of local and global pharmacovigilance operations with the ability to navigate complex regulatory environments.  

Participants will leave this course having:  

• Understood the importance of pharmacovigilance and its role in ensuring patient safety.  

• Understood the role of pharmacovigilance in the various stages of the product lifecycle 

• Understood the development of safety documents throughout the product lifecycle 

• Understood which documents are key in pharmacovigilance 

• Understood the importance of sharing relevant data with pharmacovigilance 

• Definition of an adverse event and know how to identify and report it.   

• Ability to identify sources of adverse event reports and understand how they are evaluated and assessed.   

• Knowledge of how to handle adverse event reports through a case handling exercise. Understood how safety data is pooled, presented in aggregate safety reports, and used in the signal detection process.   

• Understood the responsibilities of the QPPV  

• Understood the requirements for setting up  the pharmacovigilance system master file (PSMF), SOPs, contracts, training, and measuring compliance performance.   

• Connect with other professionals in the field, creating opportunities for collaboration and knowledge sharing beyond the training session. 
   

Who should participate?  Pharmacovigilance department stakeholders looking to gain a basic understanding of GVP rules, regulations and the importance of sharing data with pharmacovigilance. As well as individuals who are curious about what PV entails and seek a broad overview of its principles and practices. No prior knowledge is required. This is also suitable for individuals who are curious about what pharmacovigilance entails and seek a broad overview of its principles and practices. No prior knowledge is required. 
 

Logistics: The course is held in person and the duration is one day, from 9 AM to 4 PM. The course will be held in person at Pharma IT's office in Copenhagen (Skelbækgade 2, 1717 København). 
 

Your purchase includes: 

• Meeting materials 

• Breakfast, lunch & afternoon snack 

• Certificate of course completion 

• 1-year free membership to the Pharma IT Network