About

The German Pharmacovigilance Day returns after the pandemic break to catch up on pharmacovigilance topics that evolved in the last 3 years, such as:

  •  how Artificial Intelligence can help tackle the workload in PV
  •  new regulations (e.g. EU Clinical Trial Directive) which impact PV activities
  •  the recent letter from EMA regarding the international transfer of personal (health) data from EudraVigilance
  •  the implementation of the ISO IDMP Standards
  •  setting up a global structure of PV System
  • how to manage interactions between Headquarter and Affiliates in PV
  • the issue of drug shortages

With all these developments, it's important to question "Pharmacovigilance: Quo vadis?" and engage in discussions about future trends and developments in the field.
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

 

Scientific Board

  • Marc Zittartz - Principal Consultant and Managing Director at Insife Germany
  • Carsten Wieser - Head Global Safety at 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.

Programme
09:00
09:30
Registration
09:30
09:40
Welcome by the Scientific Board
09:40
10:20
Bridging the Two Worlds: Assessing the Impact of the New European Clinical Trial Regulation on Medical Safety and Pharmacovigilance
Zurab Koberidze - Director Pharmacovigilance at FGK Pharmacovigilance GmbH

The field of clinical research is undergoing a significant transformation with the introduction of the new European Clinical Trial Regulation (EU CTR). This regulation aims to streamline and harmonize the conduct of clinical trials across European Union (EU) member states by simplifying and expediting their authorization process through a centralized system for application submission and assessment. This shift is expected to improve the efficiency of trial initiation, ultimately accelerating the availability of new treatments to patients.

Direct impact of CTR on Medical Safety is multifaceted ranging from explicit simplification of routine daily tasks (e.g. expedited and periodic reports submission) to implicit changes aiming to advance understanding and application of overall sponsor responsibility (e.g. signal management process). These altogether provide on the one hand important interlink between clinical development and post-approval environment for risk-benefit assessment continuum but on the other hand causes challenges for the stakeholders and especially sponsors of clinical trials in their practical implementation.

We provide initial exploration of the potential impact of the new EU CTR on medical safety and pharmacovigilance. Further research and evaluation are needed to assess the middle- and long-term effects of the new EU CTR on medical safety and pharmacovigilance in general and on EU-based pharmacovigilance service providers in particular and identify any challenges or opportunities that may arise during its implementation.

10:20
11:00
Risk management and effectiveness of RMMs
Dimitris Zampatis - Global Program Safety Lead at Sandoz International GmbH

To ensure the safety of drugs, pharmaceutical companies and regulators need to assess measures for the appropriate management of the risks of drugs at any time from the development phase to the regulatory review and the post-marketing phase.

The Risk Management Plan (RMP) is a living standalone document which entails the continuous risk management of drugs. The RMP ensures that the risks of drugs are evaluated at regular intervals or in response to the progress of post-marketing surveillance and a set of pharmacovigilance activities to minimize the risks of drugs. It lists the safety concerns of a product, important identified risks, important potential risks and missing information.

To address these safety concerns, collection of the missing information, examination of risk factors for important identified risks and causality assessment of important potential risks (the pharmacovigilance activities) or post-marketing activities such as information provision for risk minimization (the risk minimization activities) are described.

In the risk minimization activities, besides the routine risk minimization activities (such as providing information through electronic package inserts), additional risk minimization activities (aRMMs) might be required.

11:00
11:30
Coffee Break
11:30
12:10
Challenges of outsourcing local PV activities
Andrea Maulwurf - Head of Corporate Pharmacovigilance Global Leading QPPV at Bencard Allergie GmbH

Setting up a global PV system with presence in different countries worldwide may be a challenge, especially for small companies with low volumes of adverse events.

The presentation will focus on the experience with PV third party providers, including managing PV agreements and monitoring the partners locally.

12:10
12:35
Managing Interactions between Headquarter and Affiliates in Pharmacovigilance - Focus on Europe
Doris Haarbach - GCSP Region Operation Manager at CSL Behring

In an increasingly globalized world, companies have no choice but to drive their business internationally if they do not want to lag behind their competitors.

Managing Pharmacovigilance activities globally poses multiple challenges. PV Regulations have different maturity levels, Local Safety Officers may have other obligations in addition to PV (e.g. Quality, Regulatory Affairs) and have multiple reporting lines.

Activities may be defined on a global level and need to be implemented taking into account local legislations.

This presentation highlights some of the challenges, and how interactions and collaborations between headquarter and affiliates can be improved.

12:35
13:00
Hemaya - Pharmacovigilance Awareness Education Program in Middle East & Africa (MEA)
Simone Lorenz-Asmus - Head of PV Regions Europe & Eastern & Central Intercontinental, Middle East Africa at CSL Behring

To demonstrate CSL’s commitment to protecting public health and improving and saving lives of patients with rare and serious diseases, CSL Behring initiated the Pharmacovigilance (PV) Awareness project Hemaya (“Hemaya” – Arabic for “protection”) for the Middle East and Africa (MEA) region. The goals are to support local partners in order to understand their local requirements and expectations from the local health authority. We are working with our partners to introduce “The Guideline on Good Pharmacovigilance Practices (GVP)” in the country to ensure compliance according to local and global regulations for the entire company.”

As CSL expands its global footprint, the company faces various local regulatory challenges. One of the common issues that many global companies encounter is the ranging local Pharmacovigilance experience and legislation requirements.

Guided by our collaboration and superior performance values, GCSP Regions organization started this unique initiative. Within the Hemaya project, the European & Eastern & Central Intercontinental (ECI) Region Lead Simone Lorenz-Asmus and her team raise awareness in Pharmacovigilance and the implementation of local and global laws and regulations with our distributors in 21 MEA countries – with Oman, Saudi Arabia, United Arabic Emirates, Jordan, Kuwait, and Iran being the first on the list.

13:00
14:00
Networking Lunch
14:00
14:40
A Letter from EMA – International transfer of person (health) data
Marc Zittartz - Principal Consultant and Managing Director, Insife Germany

At the end of 2022, the EMA send a letter to all EU QPPVs, warning of a potential data privacy issue. As a EU Marketing Authorisation Holder, companies have the responsibility to download ICSRs from EudraVigilance. These ICSRs might also be reportable outside the EU, e.g. FDA. It was identified that during the reporting to the FDA, personal (health) data was submitted in the narrative, which has since been published on the the FDA website.

In this discussion round we encourage companies to exchange which standards were established to prevent the disclosure of personal (health) data in ICSRs and the role of affiliates and Headquarters respectively to ensure that ICSR reporting is adhering to the EU General Data Protection Regulation (EU GDPR)

14:40
15:20
Implementation of the ISO IDMP Standards and its impact on Regulatory and PV departments
Jörg Stüben - Head of Regulatory Information Management and Senior Expert at Boehringer Ingelheim

The EMA is implementing the ISO standards for Identification of Medicinal Products (IDMP) to manage all information related to medicinal products as part of their SPOR project. This implementation has been started several years ago and did only progress slowly but recent developments start to more visible and creating impact. This presentation aims to explain the concept of the global IDMP standard and its implementation in the EU context, covering the cooperation of FDA and EMA as well as the impact on day-to-day operations in both Regulatory Affairs and Pharmacovigilance departments

15:20
15:50
Coffee Break
15:50
16:30
Drug shortages - a German problem? Background, reasons and solutions
Reinhold J. Schilling - Head of Global Pharmacovigilance, EUQPPV at Wörwag Pharma GmbH

In recent years, there has been a notable increase in drug shortages in a lot of countries across a wide range of medicines, including both generic and branded medicines.
The impact of drug shortages in Germany is significant and multi-faceted. Firstly, patients may face difficulties in accessing essential medicines, leading to delays in treatment, compromised health outcomes and increased healthcare costs. In addition, healthcare professionals are burdened with the task of finding suitable alternatives or adjusting treatment plans.

The causes of shortages are multifaceted, including manufacturing and supply chain disruptions, regulatory issues, market dynamics and increasing global demand for medicines.
Various strategies and initiatives have been proposed to address these. One key approach is to improve communication and collaboration between stakeholders. Improving transparency and information sharing between pharmaceutical manufacturers, wholesalers, healthcare providers and regulatory authorities can help identify and address potential supply disruptions more efficiently. In addition, the establishment of a centralized database or platform to track and monitor drug availability in real time could facilitate early detection of shortages and enable proactive interventions.

Another approach is to increase the resilience of the pharmaceutical supply chain. Diversifying suppliers, both domestically and internationally, can reduce reliance on a single source and mitigate the risk of shortages caused by manufacturing disruptions.

In addition, promoting domestic manufacturing capabilities and incentivizing the production of essential medicines domestically can contribute to a more robust and self-sufficient pharmaceutical industry.
In addition, some regulatory changes have been proposed like the streamlining and speeding up the marketing authorization process as well as regulatory requirements for manufacturers to maintain a certain level of drug stock.

By implementing these strategies, Germany strives for a more robust and sustainable pharmaceutical supply system, ensuring the availability of essential medicines and safeguarding the well-being of its population.

16:30
17:10
ChatGPT as Medical Writer in Pharmacovigilance - Opportunities and Limitations
Heinz Weidenthaler - Global Principal Safety Physician at Bavarian Nordic

Generative artificial intelligence (AI) including language models such as ChatGPT and similar approaches by Google and Meta have rapidly gained popularity in a broad range of applications. AI approaches have been used in pharmacovigilance before, but previously this has been largely limited to single case processing, generation of narratives and automated readouts of source documents. Generative language models like ChatGPT have capabilities beyond standardized processes, and it is conceivable that they may be used in more complex pharmacovigilance applications. This presentation aims to review the possibilities of generative AI for various pharmacovigilance tasks, such as signalling and aggregate report writing, and will focus on actual possibilities, but will also discuss limitations and threats.

17:10
17:20
Conclusions
Speakers
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.
Zurab Koberidze
Info Speaker

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.  
Doris Haarbach
Info Speaker

Doris Haarbach

GCSP Region Operation Manager at CSL Behring
Doris worked several years in Germany and in the US as certified pharmacy technicians in several pharmacies. In 2012, her career started in the pharma industry at Mundipharma in Germany. She was responsible for the import and export of narcotic. She joined drug safety in 2014, and worked from 2014 to 2017 in case handling and creating aggregate reports for Mundipharma Research. Since 2017 she started to work for CSL Behring in Marburg, Germany as Regions Specialist, supporting global and local team members. In her current role, she is responsible for pharmacovigilance processes on global and local level and supporting them with tools.
Simone Lorenz-Asmus
Info Speaker

Simone Lorenz-Asmus

Head of PV Regions Europe & Eastern & Central Intercontinental, Middle East Africa at CSL Behring
Simone has more than 18 years of experience in the pharmaceutical industry mostly in pharmacovigilance. Today Simone is Head of PV Regions for Europe and Eastern & Central Intercontinental (ECI), CSL Behring Innovation GmbH. Her main fields of expertise are business concepts for pharma/pharmacovigilance, team development and leadership, expansion and post-merger integration. Prior to her career  at CSL Behring Simone headed the PV Operations department at Horizon Pharma and has also worked for other international big and mid-size Pharma companies. As Simone holds degrees in business and health care economics she combines the commercial and R&D perspective which enables her to consult the business in the set-up of new affiliates, processes and team management across the globe.
Andrea Maulwurf
Info Speaker

Andrea Maulwurf

Head of Corporate Pharmacovigilance Global Leading QPPV at Bencard Allergie GmbH
WORK EXPERIENCE: Since 04/2014 Head of Corporate Pharmacovigilance, EU-QPPV at Allergy Therapeutics plc, UK - from 07/2010 to 02/2014 Managing Director at Glenwood GmbH, Germany - from 07/2001 to 02/2014 Head of Regulatory Affairs & Drug Safety at Glenwood GmbH, Germany - from 01/1997 to 06/2001 Manager Regulatory & Medical Affairs at Dr. Winzer GmbH, Germany - from 07/1995 to12/1996 Manager Regulatory Affairs at Acemed GmbH, Germany - from 02/1993 to 06/1995 Quality Control & Regulatory Affairs Associate at Mucos GmbH, Germany. | EDUCATION: Dr. rer. nat. / PHD in Biophysics at University of Regensburg - Diploma Biology at University of Regensburg
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
Jörg Stüben
Info Speaker

Jörg Stüben

Head of Regulatory Information Management and Senior Expert at Boehringer Ingelheim
Dr Joerg Stueben works as “Head of Regulatory Information Management and Senior Expert” for Boehringer Ingelheim. He oversees all typical activities of a RIM group with a focus on Data Management, IDMP/SPOR and Data Quality questions. He has a record of successfully leading cross-functional and compliance critical, global projects and consults his business in complex process questions. With over 25 years of extensive experience in pharmaceutical industry, Joerg is an acknowledged expert in project and process management. He was a member of EMA´s IDMP/SPOR Task Force until it was discontinued earlier this year and is a member of the GAMP-DACH Steering Committee. He is a licensed pharmacist and six sigma black belt
Heinz Weidenthaler
Info Speaker

Heinz Weidenthaler

Global Principal Safety Physician at Bavarian Nordic
Dr. Heinz Weidenthaler is a Global Principal Safety Physician for Bavarian Nordic’s vaccines. He graduated from Technical University of Munich Medical School in 2000 and completed his MD thesis in immune-oncology. In 2022, he graduated as a Master of Public Health from Imperial College London. He joined Bavarian Nordic in 2013, initially as Qualified Person for Pharmacovigilance. From Jan-2019 to late 2022 he served as VP Clinical Strategy, a role in clinical research supporting the FDA licensure of Jynneos and the clinical development of RSV and COVID-19 vaccine candidates from Phase 1 into Phase 3. Since 2023 he has been working on the post-authorization benefit risk profile of the Imvanex/Jynneos smallpox and mpox vaccine. In the recent years, he was regularly invited as a guest speaker on CDC and WHO poxvirus related panels and advisory committees. He has been involved in research on mpox and COVID-19 from a vaccine manufacturer’s perspective.
Dimitris Zampatis
Info Speaker

Dimitris Zampatis

Global Program Safety Lead at Sandoz International GmbH
Dimitris Zampatis, MSc, MSc, PhD, works currently as Global Program Safety Lead at SANDOZ International GmbH. He holds a BSc in Biology, a MSc in Medicinal Chemistry: Drug Design and Development, a MSc in Health Policy and Planning and a PhD in Cell and Molecular Biology. In his current role he is responsible to provide 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 role as QPPV, he was overall responsible for all pharmacovigilance of all medicinal products for which the company holds marketing authorizations within the EU as also was heading the PV department for the EMEA region. 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).
Contacts

Francesca Archetti
Events and Training Manager
francesca.archetti@lsacademy.com

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


Registration Fee

€ 590,00 Early Bird fee until 19 August 2023
€ 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.

 


Useful Information

The conference will take place at:

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

Past Conferences
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
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<p style="text-align: center;"><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p>&nbsp;</p>

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

 

<p style="text-align: center;"><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p>&nbsp;</p>
<p style="text-align: center;"><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p>&nbsp;</p>
<p style="text-align: center;"><strong>Hotel nhow Frankfurt</strong><br />
Brüsseler Str. 1-3<br />
60327 Frankfurt am Main, Germany</p>
<p>&nbsp;</p>