Signal Management in Pharmacovigilance MasterClass - US edition
27-28 November, 2023
The focus of this two half day training will be on providing an update of ongoing activities regarding medicines’ signal management.
During the two half training days participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management sessions, pragmatic approaches, real life examples, lessons learned, as also processes for signal management will be discussed.
27-28 November, 2023, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
Overview
The focus of this two half day training will be on providing an update of ongoing activities regarding medicines’ signal management.
During the two half training days participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management sessions, pragmatic approaches, real life examples, lessons learned, as also processes for signal management will be discussed.
Finally, during this training an outlook of the interactions between Drug Safety and other internal (e.g. Regulatory Affairs) and external stakeholders (health Authorities) will be given. How we communicate efficiently signals, Emerging safety issues (ESISs) and other safety communications (i.e. DHPCs) will be discussed.
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RECOMMENDATION
Who should attend?
• Individuals involved in risk management planning, risk minimisation development and post authorisation safety studies at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
• Risk communication experts
• Qualified Persons responsible for Pharmacovigilance (QPPVs)
• Individuals involved in pharmacovigilance, safety database, signal management and information management
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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