Introduzione

The German Pharmacovigilance Day returns to Frankfurt to look at evolving topics in pharmacovigilance. Although we are governed by one EU framework, there is enough space for interpretation depending on countries, the type of products one manages and new challenges arising, We are looking at a wide range of topics such as:

  • Social media and PV - Hurdles and solutions for mid-size pharma companies
  • Weight loss drugs – the new blockbusters and their emerging safety profile
  • Risk minimization measures
  • Swissmedic - How to deal with the new ICSR reporting requirements related to risk assessment
  • Pharmacovigilance and pregnancies - what to do if the patient cannot just stop taking the drug
  • Pharmacovigilance across borders – Sharing experience
  • Artificial Intelligence – the emerging picture for regulation in pharmacovigilance

The German Pharmacovigilance Day provides an opportunity for professionals to come together, exchange knowledge and experiences, and explore innovative solutions to the challenges faced in pharmacovigilance. By sharing insights and discussing potential solutions, we can collectively advance the field of pharmacovigilance and ensure the safety and well-being of patients.

Conference language: ENGLISH


The Scientific Committee:

Marc Zittartz, Principal Consultant and Managing Director, Insife Germany
Carsten Wieser, Head Global Safety, Dr Falk Pharma


Who should attend?

The conference program is designed for healthcare professionals or pharmacists working in the pharmacovigilance units in the pharmaceutical industry or regulatory agencies, either as specialists or managers, QPPVs, inspectors and QA personnel including auditors, employees in regulatory affairs units with close relations to pharmacovigilance, vendors and CROs working with patient safety data.

Programma

The agenda will be finalized shortly, in the meantime please note that the timetable can be subject to changes.

17 September 2024
09:00
09:30
Registration
09:30
09:40
Welcome by the Scientific Board
09:40
10:10
Pregnancies and Pharmacovigilance
Geraldine Prager - Local Safety Officer Germany at UCB Pharma

Worldwide approximately 200 million women become pregnant each year. Millions of women around the world are considering starting or expanding their families, while living with a severe chronic disease. Many chronic severe diseases are more common in women than men, and often manifest in early adulthood, overlapping with peak reproductive years for women.
However, these women and their healthcare providers often lack the necessary information to make informed decisions about managing their disease during pregnancy and breastfeeding. Does the drug continuation cause any harm to my baby? Does the discontinuation of the therapy or even unadopted dosing cause any harm to my patient?
Unfortunately, many women must trade-off between controlling their disease and family planning: pregnant women are usually excluded from clinical studies and therefore medicines are generally contraindicated or considered unsafe during pregnancy.
In addition, it shouldn’t be missed to include men. There is also a need to further explore the safety of paternal exposure and its potential effect on the pregnancy.
This presentation will reflect what sources of information are currently available to support parents to be and their physicians to take a decision regarding disease management and wellbeing of the baby. Furthermore, the presentation includes examples on how to process a pregnancy report, monitor drug administration during pregnancy and what initiatives could be put in place to receive as much information as possible.

10:10
10:40
An Independent Safety Insight on Weight Loss Drugs Leveraging Open Data and Open Source Methodologies
Lionel Van Holle - Founder of OpenSourcePV

OpenSourcePV promotes the use of open source technology and open source data (FAERS, VAERS) for performing safety monitoring without relying on either the transparency of the Market Authorization Holder, the regulatory authorities or the access to expensive software on the shelf.

After having started by monitoring vaccine spontaneous report data for vaccines such as shingle vaccine during mass vaccination, the covid19 vaccines during pandemic and the RSV vaccine, OpenSourcePV leverages new open source packages such as Diana and expands the scope to drugs to try to answer public concern regarding some drugs, originally developed to treat type-2 diabetes but massively used off label.

This presentation will present exploratory results using publicly FDA data from FAERS and quantitative signal detection methods such as disproportionality but also time-to-onset signal detection and cluster analysis.

10:40
11:10
Coffee break
11:10
11:40
Risk Management and Risk Minimization Measures - Authority Perspective
Martin Huber - Safety and Pharmacovigilance Expert, Vice-Chair of the PRAC

Abstract available soon

11:40
12:10
Risk Management and Risk Minimization Measures - Industry Perspective
Henry Barton - Global Safety Lead at Grünenthal

Abstract available soon

12:10
13:25
Lunch
13:25
13:55
Navigating Social Media and Pharmacovigilance: Challenges and Solutions for Mid-Size Pharma Companies
Reinhold J. Schilling - Head of Global Pharmacovigilance, EUQPPV at Wörwag Pharma GmbH

Social media plays a pivotal role in the marketing of over-the-counter (OTC) medications in Europe, offering tailored advertising to specific target groups.

Consumers interact with social media advertising through actions like liking, sharing, commenting, and contacting pages via private messages, contributing to the dynamic nature of engagement.

While “literature” is extensively referenced in GVP Module VI, “Social Media” is notably absent, reflecting a regulatory lag in addressing this modern communication channel. Limited guidance is provided on managing “digital media”, with no specific mention of sponsored social media channels, despite the surge in platforms like Instagram and TikTok post-2011.

Many pharmaceutical companies are retreating from social media due to perceived challenges, as evidenced by a survey conducted in collaboration with the Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Concerns primarily revolve around the workload associated with handling adverse reaction reports. However, our consumer survey found that only a minuscule 2% of reported side effects were through social media channels.

In my presentation, a solution is offered that enables your marketing team to maintain social media presence while ensuring clarity and guidance on internal workflows and information dissemination.

Navigating the intersection of social media and pharmacovigilance presents significant challenges for mid-size pharmaceutical companies. However, with strategic approaches and innovative solutions, these hurdles can be overcome, ensuring regulatory compliance and effective engagement with consumers.

13:55
14:25
Ensuring continued reliable use of Artificial Intelligence
Christian Schmitz-Moormann - Owner at Pharma Process System Consult

Abstract available soon

14:25
14:55
Coffee break
14:55
15:25
Swissmedic News: Exploring Recent Safety Updates and Its Implications in a Swiss Affiliate's Day-to-Day Operations
Sabine Poltermann - Head of Country Patient Safety Switzerland at Bristol Myers Squibb AG

This presentation delves into the impact of recent safety updates from Swissmedic on the daily operations of a Swiss affiliate (Risk Management Plans, ICSR processing, electronic exchange). By examining the regulatory changes and their practical implications, this session aims to equip attendees with the knowledge and strategies necessary to navigate these updates successfully.

The presentation begins by providing an overview of the latest safety updates issued by Swissmedic. Through real-life examples and case studies, the audience gains insights into the practical implications of these updates and the challenges they pose.

The session emphasizes the importance of compliance and highlights strategies for integrating the safety updates seamlessly into day-to-day operations. Building strong relationships and fostering a culture of compliance and continuous improvement are also discussed.

By attending this presentation, participants will gain a comprehensive understanding of the recent safety updates from Swissmedic and their implications for day-to-day operations.

Join us on this enlightening journey through the Swissmedic Chronicles and discover the keys to success in navigating safety updates in a Swiss affiliate.

15:25
15:55
Topic to be Announced
Zurab Koberidze - Director Pharmacovigilance at FGK Pharmacovigilance GmbH
15:55
16:00
Closing Remarks by the Scientific Board
Relatori
Marc Zittartz
Info Scientific Board

Marc Zittartz

Principal Consultant and Managing Director, Insife Germany

Marc has been crossing the frontier between IT and R&D in the pharmaceutical industry in Europe and the USA for more than 15 years. He supports R&D divisions to improve their business processes through the optimized use of information technology.

Today Marc is Principal Consultant at Insife. His main fields of expertise are business processes and applications for pharmacovigilance, supported by proven knowledge in international team leadership, project management, computerized systems validation, and business intelligence.

Prior to his consulting career Marc headed the Drug Safety IT and Application Management groups at UCB and Grünenthal, respectively. In these roles he was the project leader for the implementation or upgrade of Pharmacovigilance IT systems, with experience in designing and implementing signal detection and management systems.

As an expat for Schwarz Biosciences Inc. (USA), Marc Zittartz gained experience in a cross-cultural environment as well as in clinical development.

The cross-border insights into both clinical development and regulatory affairs gives Marc a unique perspective and enables him to advice clients in the process of choosing and implementing the right solutions to optimize their PV.

Carsten Wieser
Info Scientific Board

Carsten Wieser

Head Global Safety at Dr Falk Pharma

Dr. Carsten Wieser studied pharmacy at the University of Regensburg. He then worked – as part of his dissertation – at the Institute for Clinical and Molecular Virology in Erlangen. He began his professional career as a Medical Expert Drug Safety at Novartis Pharma GmbH in Nuremberg. From 2009 to June 2022, Dr. Wieser held various positions of increasing responsibility at Grünenthal GmbH, most recently as Director Regulatory Affairs & Drug Safety DACH. Since July 2022, Dr Wieser has been Deputy General Manager Quality, Regulatory & Safety at Mitsubishi Tanabe GmbH. Starting from August 2023, he is Head Global Safety at Dr Falk Pharma.

Henry Barton
Info Speaker

Henry Barton

Global Safety Lead at Grünenthal

Henry Barton is a physician and pharmacovigilance expert with a expertise in surgery, anesthesiology and drug safety. He has over a decade of hands-on experience in various clinical settings, including intensive care and emergency medicine.

As a Global Safety Lead at Grünenthal, Henry oversees the pharmacovigilance activities around several post-marketing products, such as esomeprazole and zolmitriptan. He is also responsible for designing and implementing risk management strategies, including innovative software solutions, which simplify workflows and enhances the efficiency of drug safety monitoring and risk mitigation. He is also deeply involved in the creation and submission of risk management plans, with a special focus on the anonymization of privacy-sensitive data and the protection of confidential corporate information. Furthermore, Henry has a profound interest in benefit-risk methodology and its use to navigate complex assessments that confirm the positive benefit-risk balance of medicinal products.

Zurab Koberidze
Info

Zurab Koberidze

Director Pharmacovigilance at FGK Pharmacovigilance GmbH

Zurab Koberidze has over 25 years of experience in clinical trials, health care management, medical safety and pharmacovigilance. Having gained his degrees from State Medical University in Tajikistan and University of California at Berkeley in US and before joining FGK, Dr. Koberidze conducted clinical studies and worked in hospital settings afterwards spending several years working for a charity in developing countries. His medical safety and pharmacovigilance expertise for the last 12 years at FGK covers among others design and management of study specific and IMP-wide global safety sentinel systems that can transition to post-marketing pharmacovigilance activities, which he oversees for many clients as a EU Qualified Person for Pharmacovigilance.

 

Martin Huber
Info Speaker

Martin Huber

Safety and Pharmacovigilance Expert, Vice-Chair of the PRAC

Dr Martin Huber is the German member of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Since October 2018 he is the vice-chair of the PRAC. In addition, he is also chairing the Non-prescription medicinal products Task Force of the CMDh since May 2017.
Being a pharmacist by training and holding a degree in public health he gathered comprehensive experience in pharmacovigilance in a hospital setting both in Germany and Switzerland before entering BfArM in 2010. Since 2013 he has been head of the unit ‘PRAC and other Committees’, and since 2017 he is head of the unit ‘PRAC, Legal Status, Adverse Reaction Reports, Medication Errors’ within BfArM’s division of pharmacovigilance.

Sabine Poltermann
Info Speaker

Sabine Poltermann

Head of Country Patient Safety Switzerland at Bristol Myers Squibb AG

Sabine Poltermann is a veterinarian with extensive experience in pharmacovigilance roles at local, regional, and global levels in various companies, including CROs, generics, and originator companies. She has a strong passion for the Spanish language, Latin music, and beaches, which led her to move to Panama and work as a Drug Safety Lead for the Latin American region.

Throughout her career, Sabine has held multiple pharmacovigilance positions, ranging from standard PV activities to ensuring compliance in patient support and market research programs, digital initiatives, and the local implementation of Risk Management Plans.

Prior to her current role as Head of Patient Safety Switzerland, Sabine served as the responsible person for product information (Informationsbeauftragte) and acted as an agile product owner, overseeing the development of an end-to-end product management flow.

Geraldine Prager
Info Speaker

Geraldine Prager

Local Safety Officer Germany at UCB Pharma

Geraldine Prager studied biology at the University of Bayreuth and then worked at the department of psychoneuroimmunology at the University of Essen. In 2013, she began her professional career as Junior Drug Safety Manager at UCB Pharma GmbH in Monheim am Rhein. From this date to 2023 she held various positions of increasing responsibility – since 2019 Graduated Plan Officer and most recently also as Local Safety Officer Germany. Since mid 2022 Geraldine Prager also supports the Qualified Person for Pharmacovigilance as additional deputy and could expand her knowledge from local and regional to global level. Throughout her carrier she managed different topics from case processing, patient support programs, aggregate reports, implementation of risk minimization measures, quality management system, audit and inspection up to vendor management.

Reinhold J. Schilling
Info Speaker

Reinhold J. Schilling

Head of Global Pharmacovigilance, EUQPPV at Wörwag Pharma GmbH

EDUCATION: Study of Chemistry in Bonn (University of Bonn), Master of Drug Regulatory Affairs (University of Bonn) |

PREVIOUS POSITION: Teacher (Chemistry + Physics) in 2011, Drug Safety Junior Manager at UCB Pharma in 2011-2012; Manager Regulatory Affairs at Mucos Pharma in 2012-2014; Stufenplanbeauftrager, Informationsbeauftragter (DE+AT), various positions in Regulatory Affairs and Pharmacovigilance from 2014 to 2021. |

PRESENT POSITION: Head of Global Pharmacovigilance, QPPV, Stufenplanbeauftragter since 2021 |

INTERESTS/ EXPERIENCES: Member of the BPI Working Group for Pharmacovigilance; Guest Speaker at the Hochschule Reutlingen since 2023

Christian Schmitz-Moormann
Info Speaker

Christian Schmitz-Moormann

Owner at Pharma Process System Consult

After working for more than 15 years helping innovators from around the world launching communication, medical device and software products in the German-speaking markets, also providing training and support for those products, Christian fully moved into the GxP domain 20 years ago and helps large and small companies getting their regulated processes and systems right. His main topics are Quality, Pharmacovigilance, and Learning.
A biochemist by formal education, Christian was responsible for the validation of strictly regulated systems and led teams bridging the gap between business and IT. At a major software vendor in the Pharmacovigilance domain he worked with customers on successfully matching processes and systems and guided teams on creating compliant tools, leveraging agile and lean practices in a strictly regulated software manufacturing environment. For the past years he has been helping clients as an independent consultant, project manager, and trainer in projects to stay on top of rapidly changing technology while improving quality, compliance and value. With the evolution of machine learning, language models large and small, AI and GenAI, Christian works with clients to identify how these new tools can be added to the industry`s toolbox for use in regulated environments.

Lionel Van Holle
Info Speaker

Lionel Van Holle

Founder of OpenSourcePV

Lionel Van Holle is an experienced pharmacoepidemiologist with a demonstrated history of bringing innovation and new ways of working. He faced two pandemics (H1N1, Covid) and several mass vaccinations when working for GSK Vaccines where he developed the in house Signal Mining and Management system. He subsequently created OpenSourcePV in 2019 with the aim of building of suite of pharmacovigilance tools using open source technology to make safety transparent and accessible.

Contatti

Francesca Archetti
Marketing and Sales Specialist
francesca.archetti@lsacademy.com

Roberta Alberti
Events and Training Manager
roberta.alberti@lsacademy.com


Quote di iscrizione

€ 590,00 Early Bird fee until 16 August 2024
€ 710,00 Ordinary fee
€ 410,00 Freelance, Academy, Public Administration

Fee includes: seat at the conference, .pdf copy of presentations of Speakers who allow the distribution, networking lunch, coffee breaks, organisational office assistance, certificate of attendance.


Informazioni utili

The conference will take place at:

Hotel nhow Frankfurt
Brüsseler Str. 1-3, 60327 Frankfurt am Main, Germany

How to reach the conference venue:

From the airport
Closest airport: Frankfurt Airport (FRA).
Taxi: It’s a 20 minute tripfrom the airport and costs approximately 35 to 40€.
Public Transportation: It’s a 15 minute trip by ICE and a ticket costs 12,50€. It’s a 25 minute trip in S-Bahn (line 8 and 9) and a ticket costs 5,10€.

From the station
Closest train station: Frankfurt Central Station (Frankfurt Hauptbahnhof). It’s 900m from the hotel.
Closest Metro station: Festhalle/Messe. It’s 200 meters from the hotel.
By car
The hotel’s GPS Coordinates: Lat: 50.11037 Lon: 8.65361
Parking: Onsite. 3,20€ per hour, 34€ per day. EV charging station available.
Edizioni Passate
2023
Pharmacovigilance: Quo Vadis? Trends and Future Developments
2020
Pharmacovigilance: Status Quo. Issues and Challenges in Germany and the EU
2019
SIGNAL MANAGEMENT AND EVDAS/EUDAMED – WHAT, WHEN, WHY AND HOW?
2018
THE BIG CHANGES IN THE EUROPEAN PHARMACOVIGILANCE AND VIGILANCE
2017
PV and Vigilance duties and challenges in the practice: What are and might be the typical problems and how to (re)act?
2016
EU-Challenges in Pharmacovigilance/Vigilance: “Hot Topics in 2016”
2015
Hot Topics in Pharmacovigilance
Registrati
Early bird
Acquistabile fino al 16/08/2024
590,00
Ordinary
Acquistabile fino al 16/09/2024
710,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 16/09/2024
410,00
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<p><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>

Hotel nhow Frankfurt
Brüsseler Str. 1-3
60327 Frankfurt am Main, Germany

<p><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>