This course covers digital technologies from the regulatory framework to strategies, operational methods, and supporting technologies. How to exploit the wealth of up-to-date structured and unstructured pharmacovigilance related information available (from traditional and innovative sources) and comply with current and future regulations. It gives an overview of the available data in the pharmacovigilance domain and how to turn it into useable information and valuable knowledge to improve effectiveness and quality.
Scope of the training is to enable participants to make informed decisions and plan/implement strategies on the subject to manage the available pharmacovigilance information.
Who should attend?
This one-and-a-half-day training course is designed to benefit functional/technical professionals working in the pharmaceutical and healthcare system dealing with the pharmacovigilance system, such as:
- Qualified Person for Pharmacovigilance (QPPV)
- Pharmacovigilance officers
- Quality assurance
- Pharmacovigilance auditor.
- Knowledge manager
- IT manager
Coming from pharmaceutical and biotech companies, clinical research organisations (CROs) and public health centres.
- The scenario
- Current and possible future regulations
- Recent and future developments
- Volume vs. quality
- Case reports vs. intelligence
- Automated reporting
- What are the differences?
- Machine learning
- Artificial intelligence
- Data science
- Why do we need to do that?
- Examples from real life
- Challenges and rewards
- A possible approach: modular
- A use case: social networks
- A case analysis: pharmacovigilance and signal management
- Entry-level solutions
- Next-generation solutions
- Building a simple case
- The “human factor”
- How will employees react?
- What are the implications for training and career paths?
Presentation, including hands-on exercises, presentations, and debates.
At the end of the training, you will be able to
- Have a working knowledge of relevant information on pharmacovigilance and AI.
- Have a working knowledge of the new technologies that could affect PV operations in the near and medium-term future
- Select the appropriate tools and processes to implement a new technologies-based approach.
- Set up simple but specific strategies
- Interact with the tools and service vendors/providers to set up more complex solutions
- Manage and report the information
Marco Anelli, Head of Medical Affairs and Pharmacovigilance Advisory Practice – PLG (Product Life Group)
Marco Anelli has been appointed in January 2016 “Head of Pharmacovigilance and Medical Affairs Advisory Services” at PLG. Previously , Marco has been R&D Director at Keypharma, an Italy-based ProductLife Group company, and was responsible for the coordination of all clinical and preclinical aspects of projects run internally and on behalf of clients. Drawing on a career in the pharmaceutical industry that spans 25 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities. Marco has participated in and coordinated all stages of drug development – from formulation to Phase I-IV and pharmacovigilance. In addition, Marco is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries. Before joining Keypharma and PLG, Marco was Medical Affairs Director at Eurand. In recent years, has worked extensively in the fields of pharmacoeconomics and health technology assessment. He has a medical degree from Milan University, specializations in Medical Statistics and Clinical Pharmacology from Pavia University and an international master’s degree in health economics and pharmacoeconomics from Pompeu Fabra University in Barcelona. As “Deputy Chief Scientific Officer” of PLG, Marco is coordinating all delivery and research projects (internal and on behalf of clients) linked to Big Data, Knowledge Management, Artificial Intelligence and Machine Learning.