7th Annual
Global
Pharmacovigilance
Summit
14th - 15th of September 2023, Prague
(Time Zone: CEST)
Join us In-Person or Online
2 DAYS CONFERENCE
The Event!
We are very excited to welcoming you at our upcoming 7th Annual Global Pharmacovigilance Summit that will be held in the beautiful city of Prague this coming September 2023.
The summit is designed for professionals from pharma industry to keep up to date with new trends, requirements and regulations when it comes to Drug Safety and Risk Management in 2023.
Participants can explore a broad range of current and future trends via the round table discussion and interactive panel discussion, case studies etc. Offering you a strategic platform which has been crafted to enable a great opportunity for information exchange and networking with top leaders and experts from all pharma industry across the globe.
We will be looking forward to meeting you at our event!

Key Topics
– How To Support Successful Pv Inspections, According To Recent Inspection Experiences
– Collection Of Aes In The New Digital Era
– Risk Management Process For Connected Drug-devices Combination Product
– Pharmacovigilance Outsourcing : Challenges And Benefits As Part Of Company Integration Or Spin Off
– The Pitfalls Of The Eu Psmf
Some Of Our Keynote Speakers
“get inspired from the world’s leading experts”

Dr Fatima Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth

RISK MANAGEMENT PROCESS FOR CONNECTED DRUG-DEVICES COMBINATION PRODUCT
- Assessing the EU MDR requirements on device risk management process.
- Applicable legislations for risk management.
- Impact on usability engineering and human factors
- Benefit -risk assessment of connected drug-device combination products

Petros Mavrogenis
Head Vigilance Process Excellence at Novartis

COLLECTION OF AES IN THE NEW DIGITAL ERA
While the amount of available digital data is growing, and we will soon reach 44 trillion gigabytes, pharma and medical device industries use digital tools collecting vast amount of health-related data in conjunction with research, development, and commercial activities. These non-traditional data sources may contain safety, efficacy, effectiveness, and other knowledge, valuable for understanding and further characterizing safety profile of a given medicinal and medical device product. However, it is unclear what responsibilities are associated to the use of such tools and data generated/collected by them.

Valentina Mancini
Senior Director Pharmacovigilance, QPPV

HOW TO SUPPORT SUCCESSFUL PV INSPECTIONS, ACCORDING TO RECENT INSPECTION EXPERIENCES
- Quality System; risk based approach audit planning
- How to conduct Gap analysis activity
- Effective KPIs/Dashboard
- Effective communications to upper management and to other functions
- PSMF set up, management and update
- QPPV oversight

Dimitris Zampatis
Global Program Safety Lead

- Signal Detection and Management Analytics
- Risk Minimizations and Mitigation
- Signal Detection and Post Authorization Safety

Erika Barbarosie
Associate Director PV Compliance

THE PITFALLS OF THE EU PSMF
- How insufficient attention to detail leads to errors, omissions, or inaccuracies in the PSMF
- Cross-functional collaboration, a key aspect often forgotten
- Failure to update the PSMF, now what?

Cécile Valli
Head of Global Pharmacovigilance Operations chez Bausch+Lomb / Laboratoire Chauvin

PHARMACOVIGILANCE OUTSOURCING : CHALLENGES AND
BENEFITS AS PART OF COMPANY INTEGRATION OR SPIN OFF
How challenges coming from Pharmacovigilance Outsourcing can be turned into benefits during the life-cycle management of a company (acquisition or spin-off).
Who Should Attend?
Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors, QPPVs, and Heads of departments from pharmaceutical industry / industries involved in:
- Pharmacovigilance
- Drug Safety
- Safety & Risk Management
- Signal Detection
- Benefit-Risk Assessment
- Safety Evaluation
- Regulatory Affairs,
- Safety Surveillance
- QPPV
- Pharmacovigilance Operations
- PV Inspection and Audit Readiness
- Patient Support Programs
- Market Research Programs
- Clinical Safety
- Medical Safety
- Medical Information
- Pharmacoepidemiology
- PV Governance
Get 20% off Now!
Share 3 of your Main Challenges
Request The Event Brochure

Companies You Will Meet


Sponsorship opportunities
If you are looking to build awareness of your brand in the pharma industry, it doesn’t get bigger than the “7th Annual Global Pharmacovigilance Summit” that will be held in the beautiful city of Prague this coming September.
Marxo Smith Events sponsorship opportunities provide your organisation with substantial international exposure, increasing visibility of your brand and your networking capacity. We have a sponsorship package suitable for you, no matter how big or small your budget..
Download the program to see how you can get involved.












2023 EVENT SPONSORS

MS Pharm
MS Pharm is a company established by experienced experts with a view to setting the standards and providing the highest level of services. It enjoys extensive experience in pharmacovigilance and its own team of experienced reviewers and experts (physicians, pharmacists) – many of them gained their knowledge working for many years in global pharmaceutical companies. The MS Pharm experience comes also from a series of audits and inspections carried out in the company. MS Pharm domain is the monitoring of medical literature in terms of pharmacovigilance and local pharmacovigilance support in Europe, CIS, Middle and Far East countries (eg. Vietnam) based on knowledge of local national pharmacovigilance requirements in individual countries – we work with local experts in pharmacovigilance.
The top quality of our processes, quality management system and their compliance with GVP requirements are confirmed by the Certificate of compliance obtained for the second time in 2020 after the independent audit.
We are focused on local medical literature monitoring and local pharmacovigilance services across the Europe and CIS countries.
Our advantages are:
- extensive experience (collectively, over 300 years of experience in pharmacovigilance)
- own team of local reviewers and experts (physicians, pharmacists)
- knowledge of local pharmacovigilance requirements
- regular quality control of all processes
- own validated tools that allow to automate the processes
Our goal is to become a leader in medical literature monitoring and set standards in this area. We aim to be a partner you can rely on.

DrugCard
DrugCard is a cost-effective full-regulatory compliant software designed to automate medical literature monitoring for drug safety departments. With DrugCard, pharmacovigilance professionals can make important decisions without deep dive into a routine. As our software provides automated weekly medical literature screening, storing, and analyzing safety information following GVP requirements. So, with DrugCard, you will have no deficiency on audits and inspections.
- automated local MLM in more than 100 languages
- access journals which not included in international databases, including printed publications
- stay up to date with daily email notifications
- unbreakable IT infrastructure that is designed by industry leaders and certified by SOC type 2/3 and ISO/IEC 27001:2013
- automated reports and records about all your GVP activity
DrugCard replaces the manual reading of journals by PV specialists, reducing the dependence on human resources and the cost of drug safety activities. Typically, DrugCard implementation takes only one week, so you could start saving money on PV activities instantly.
DrugCrads organizing giveaway of the famous Ukrainian postal stamp “Russian warship go… ” at the event to support the Ukrainian people.
Arriello
Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry. We’ve been making the development-to-market process faster, better, and smarter since 2008.
Our global services span the product lifecycle from Clinical to post-submission Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, and innovative automation solutions.
Headquartered in Ireland, with operations across Europe, we consult and create solutions across the EU, North America, LATAM, CIS, MENA, Asia, and South Africa.
With our extensive global network, decades of combined experience and ISO:9001 certification, we are a trusted partner primarily to pharmaceutical and biotech companies.
Our valued clients rely on our ability to deliver, however complex their requirements, through our proven expertise, global coverage, and technology.
Testimonials:
Feedback:






