ExpertFORUM Pharmacovigilance 2019
Your regulatory update about all aspects about drug safety in Europe
- Updates on all relevant PV-topics
- Latest information on legal issues
- Implications for pharmacovigilance processes
- Signal Management and EudraVigilance
- Educational material - inventory & outlook
- Quality & Safety - defining the interface
- Vendor management: Defining KPIs for quality assurance
- Dealing with pharmacovigilance literature - Search strategies
- Safety Labelling
- Resource planning and budget control in drug safety
- and further topics
This distinguishes our event
Aims and objectivesFORUM Institut and the conference chairs are pleased to welcome you to this year's ExpertFORUM Pharmacovigilance.
This conference has become a jour fixe for drug safety departments in the pharmaceutical industry. As always, we will highlight the latest regulatory developments and their implications for the pharmaceutical industry, and provide concrete suggestions for your daily work. We will also provide the latest information on current pharmacovigilance issues.
It is also aimed at senior executives at public authorities and research institutions, and in:
- Medical Affairs;
- Regulatory Affairs;
- Clinical Research; and
- Quality assurance.
(09:30 Uhr registration)
Day 2: 09:00 - 16:00
11:45 Coffee break
- Educational material in Germany and beyond - an inventory
- Main focus of educational material in the EU
- Do's and Don'ts
- How to measure effectiveness of educational material
- Role of PRAC, the Pharmacovigilance legislation and its impact on label changes
- PV inspection findings and their impact on labeling processes
- Deviation Management and harmonisation of local labels
16:00 Coffee break
- Responsibilities and reporting in case of lacking quality
- Reporting channels and reporting deadlines
- Who is responsible: QP, national PV officer, QPPV, etc
- Product batch release - Role of the safety department
18:00 End of day 1
- Type of literature sources: Individual cases, meta-analyses, clinical studies, cumulative reports, congress information - where to find what?
- Medical Databases and Search Engines: Advantages and Disadvantages
- Automated methods
- Duplicate management
- How do you assess the quality of external data?
- Relevance? Implementation in practice
- How do I document an efficient research strategy?
10:45 Coffee break
- What resources are required?
- How much manpower is needed?
- What workload should be expected?
- What to do in the case of lacking staff?
- Compiling costs and resources
- Adapting budget & avoiding budget overrun
- Department budget vs project budget
16:00 End of the conference
Nähere Informationen finden Sie hier.
Deputy EU-QPPV & Head PV Intelligence Senior Pharmacovigilance Expert, Deputy EU-QPPV, Experience in Risk Management, Global Labeling, Drug Development
Head of Global Labeling
Senior Expert Pharmacovigilance, Bonn, Germany
CEO & Co-Founder; Oliver has a background in computer science and media. As Co-Founder and Chief Executive Officer of the inhive Group, among his background as an entrepreneur for more than 15 years, he brings many years of experience in strategic and IT projects in Life Science, Health Care and other heavily regulated industries. Leading the inhive team in working with large global clients, he enjoys steering and advising projects in both strategy and technology. He is passionate in helping clients execute their vision successfully while buliding partnerships and teams that can deliver.
Nähere Informationen finden Sie hier.
Senior Expert International Pharmacovigilance Process Liasion, International Pharmacovigilance Tanja is a physician, holding advanced degrees in health economics, medical quality assurance and pharmaceutical medicine. After a few years' experience as a physician, she is now engaged in various positions in local and global pharmacovigilance, including a long-term engagement as Head of Regional PV, Head of EU PV as well as PV process expert in the international arena. Her specialities are international PV affiliate networks, interaction between local and global PV departments, PV resourcing and risk minimisation.
Phone: +49 621 336990
Fax: +49 621 33699-2100
- Intensive discussion with pharmacovigilance leaders and authorities.
- Relevant expertise, including practical examples and projects.
- Sufficient time to address related issues.
Topics well selected and prepared.
Discussion of current topics like BREXIT, Data Privacy. Got impression how other parties handle these topics.
Many experts were there. A broad knowledge was provided.
Highly relevant topics. Very experienced and knowlegable speakers.
Interactivity and information exchange.
Interactive sessions, time for discussions.
Exchange with colleagues. Interactive mode.