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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.

Signal Management in Pharmacovigilance MasterClass - US edition

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

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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.

#masterclass      #glceurope      #pharmaonlinemasterclass    #globalleadingconferences      #signalriskmanagementpharmaUS

Trainer
Dr. Dimitris Zampatis MSc, PhD
Dr. Dimitris Zampatis MSc, PhD
Global program Safety Lead
Sandoz
Dimitris has got 12 years of experience in providing strategic input into safety aspects of assigned product(s), lead the pharmacovigilance processes and product safety reviews, review SOPs and guidelines, provide scientific input in signal, risk management and benefit risk assessment outputs and reviews and act as key person for regulatory or internal audits and inspections.

In his previous roles as safety expert, he was responsible for the development of the company’s benefit-risk assessment framework, the signal detection strategy e.g., quantitative, and qualitative signal detection methods using internal and external databases (EVDAS, VigiBase, FAERS, VAERS, JADER) as also the Risk Management and risk minimization measures processes and implementation. Through his career Dimitris gained substantial and solid knowledge and experience in different aspects of Drug Safety and Pharmacovigilance such as Signal Detection, RMPs, PBRERs/ PSURs, DSURs, safety communications (e.g., Direct Healthcare Professional Communication/ Dear Investigator Letter). He participated in various successful FDA and EMA submission applications either as a team member or as team leader.

Dimitris is a Pharmacovigilance tutor and trainer and participates in various conferences as a speaker. Also, Dimitris is a guest lecturer at the Master of Science (MSc) program Drug and Regulatory Affairs of the Pharmaceutical Department of the University of Nicosia (Cyprus).

Dimitris is biologist by training, acquired a MSc in Medicinal Chemistry from University of Patras in Greece, a MSc in Health Policy and Planning from the Open University of Cyprus and he holds a PhD in Cell and Molecular Biology from Free University of Berlin.

Who should attend imgRECOMMENDATION

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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3,410

Speakers

17,761

Attendees

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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