German Pharmacovigilance Day - Relatori

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.

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 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 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 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.

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

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

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

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, 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).