Date

3 June 2020

Location

Virtual

Language

German

German Pharmacovigilance Day Virtual

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German Pharmacovigilance Day Virtual

Covid-19 is creating the biggest international emergency nowadays. But German Pharmacovigilance Day doesn’t stop, the conference will move to a new format: GERMAN PHARMACOVIGILANCE DAY VIRTUAL. 

4 hours live event, divided in 2 sessions (morning and afternoon), with slots for Q&A and discussion among delegates. Join the virtual conference and keep you updated about the most interesting pharmacovigilance topics in Germany!


Pharmacovigilance: Status Quo.

Issues and Challenges in Germany and the EU 


LS Academy welcomes you to the 6th German Pharmacovigilance Day to be held on 3rd June 2020 in virtual format.

Pharmacovigilance processes and activities are continuously subject to evaluation and revision based on the experience gained by marketing authorization holders and health authorities. The German Pharmacovigilance Day event will provide a status quo of the drug safety and pharmacovigilance topics that currently have a major impact in the European Union, with an emphasis on Germany.

Among the main topics of the day:

  • News from the EMA in pharmacovigilance
  • Update on the EMA pilot project on signal management 
  • Safety concerns: challenges for risk management plans and periodic safety update reports
  • Update on HaRP (Harmonisation of RMP Project): first experiences, pro’s and con’s, what should be improved
  • Risk Minimisation Measures: Educational materials and “Rote Hand Brief”
  • How PV can benefit from social media, artificial intelligence and apps 

German and European subject matter experts will share their experience and present the challenges posed by the regulatory environment from the industry and the health authority’s perspective. Meet inspiring speakers and experts at our German Pharmacovigilance Day presenting hot-topics on safety and pharmacovigilance. Participants will have the opportunity to share their knowledge and bring practical examples to a benchmarking session at the end of the event. 

The German Pharmacovigilance Day traits include:

  • A Scientific Committee guaranteeing updated and strictly scientific topics, quality discussions and absence of any commercial presentations
  • Different perspectives presented over the event: regulatory authorities, industry, CROs
  • Each presentation is fully reviewed by matter experts before approval
  • Working and open discussion sessions such as benchmarking ones
  • Notable networking opportunities
  • An event taking place in Berlin and presenting local and European perspectives in German
  • An easy to access venue and friendly environment

The event is designed for professionals involved in safety, pharmacovigilance, clinical research, development and management of pharmaceutical products. LS Academy, leader in the field of scientific continuing education, welcomes you to an outstanding Pharmacovigilance event for constant professional development and up-to-date discussions in this extremely relevant scientific area.


Scientific Board:

Tiziana Von Bruchhausen - Senior Pharmacovigilance Writer at Boehringer Ingelheim

Boris Thurisch -  Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association


Who should attend?

This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care area dealing with the Pharmacovigilance system, such as: Safety and Pharmacovigilance dept, Clinical operation dept, Statistic dept, Medical Affairs dept, Medical Information dept, Regulatory Affairs dept, Quality & Compliance dept, Legal dept, Software Developing dept, Medical Devices Manifacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students). Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.


For sponsorship opportunities, please contact events@lsacademy.com



Certificate of attendance

Certificate of attendance

3 June 2020

The Pharmacovigilance Risk Assessment Committee (PRAC) has been in the centre of EMA’s pharmacovigilance activities since its establishment in 2012. PRAC is responsible for a wide range of different tasks, with referrals and signals being important pharmacovigilance tools. Referrals are comprehensive safety reviews leading to a recommendation to either maintain, vary, suspend or revoke the marketing authorisations of the products involved. Some of the recommendations of PRAC had a large public health impact, whilst others have been taken up controversially by stakeholders.

The session will provide insights into recent developments and will also highlight the most relevant procedures dealt with by PRAC. General trends will be discussed and future challenges explored.

Nicole Bick Nicole Bick – Safety and Pharmacovigilance Expert

Pharmacovigilance data summaries have started from line-by-line representation of ICSRs, and tabulations of adverse event frequencies. Unlike experiments, where data is collected per protocol and results derived through pre-defined statistical tests, PV information will often share analytical challenges with big data, due to its volume, variety, velocity, and sometimes uncertain veracity. 

Decision makers in PV rely on analytical pre-processing of information (including transformation, selection, and illustration), and the presentation of PV data often starts from aggregates, like all ICSRs associated with a medicinal product. Drill down decisions need to balance the need for a systematic review of subsets (to safeguard completeness and objectivity) with a capacity to respond to ad-hoc observations as unveiled by exploratory steps, often under prescribed timelines.

This presentation will discuss two data analysis scenarios, and offer solution proposals for challenges:

A: PBRER presentation of signals and product risks, when complicated by substantial period-to-period changes (longitudinal follow-up of patients, patient support programs)

B: EudraVigilance and FAERS public dashboards. Two different approaches to data transparency, and associated regulatory expectations.

Ulrich Vogel Ulrich Vogel – Head of Strategic Data Analysis at Boehringer Ingelheim International

Changes in EU pharmacovigilance (PV) legislation over the recent years aimed at increasing transparency, encouraging consumer reports of adverse events (AEs) and obligating pharmaceutical companies (MAHs) to monitor social media. In 2018, reports to EMA increased by 89% overall and by 91% from patients as compared to 2017. Data from patients or in social media are often less structured and of lower quality than those from pre-approved forms. Manual approaches to data analysis are not feasible for large size or too time- and labor- intensive and error-prone. Artificial intelligence (AI) was able to significantly increase efficiency by reducing time, costs and errors in data analysis and enabled MAHs to close previous gaps in AE reporting thereby meeting regulatory post-inspection demands. However, AI faces challenges: ensuring data privacy and safekeeping in compartments to prevent data exchange between various servers and unwanted access by others. Capture of PV relevant information should be quick, easy for health care providers and patients and possible in different languages. For this purpose, the Adverse Event Tracker (AETracker) was developed: it analyses structured and unstructured data from CRM and audio sources, identifies duplicate information and exports PV relevant data in a format compatible with established PV data bases, e.g. Eudravigilance for ease of reporting. Results of AETracker use (retro- and prospective, including social media and apps) will be presented.

Eva-Maria Westphal Eva-Maria Westphal – Associate Director and Engagement Manager (Pharmacovigilance), Global Tech Solutions, IQVIA

Current developments in the field of "Rote-Hand-Briefe" and educational materials in Germany will be discussed. It will be highlighted when and how materials should be developed: how can we provide important information, what to consider? The session will address the challenges that the pharmaceutical industry is facing in this context. Furthermore, the importance of digitalisation methods will be emphasized, exploring potential approaches and how these can be implemented. How are we going to handle this challenge? 

Boris Thurisch Boris Thurisch – Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association

Current developments in the field of "Rote-Hand-Briefe" and educational materials in Germany will be discussed. It will be highlighted when and how materials should be developed: how can we provide important information, what to consider? The session will address the challenges that the pharmaceutical industry is facing in this context. Furthermore, the importance of digitalisation methods will be emphasized, exploring potential approaches and how these can be implemented. How are we going to handle this challenge? 

Boris Thurisch Boris Thurisch – Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association

Evaluating the effectiveness of additional risk minimization measures is necessary to establish whether risk minimization objectives designed to minimize or mitigate serious risks for marketed  drugs have been met or not. The EMA requirements, which are clearly delineated in GVP Module XVI, stipulate that an effectiveness evaluation should address three different aspects of risk minimization: the process, the impact on knowledge and changes in behavioral in the target audience and the outcome. While the available methodology for the design and implementation of different effectiveness measures to evaluate process indicators covering the first two aspects is well established, good communication and collaboration between different parts of an organization are required for compliant implementation. Effectively evaluating outcome indicators often presents greater strategic and methodological challenges, especially when also ensuring that the burden to the healthcare system or other key stakeholders is commensurate. Case studies will be used to illustrate the challenges with different types of measurements of the effectiveness of additional risk minimization measures. Overall, a more systematic approach is required.

Monika Borchert Monika Borchert – Deputy EU-QPPV Head at Novartis

The safety concerns of a medicinal product are defined during clinical development and carried forward into the post-marketing phase through the risk management plan (RMP). The preparation of pharmacovigilance documents during the life cycle of a medicinal product is related to ongoing activities, which include interactions of the marketing authorisation holders (MAHs) with health authorities, periodic safety update reports (PSUR) submissions, and possible RMP updates. For the RMP, the definition of safety concerns was revised in the European Union (EU) with the Good Pharmacovigilance Practice (GVP) Module V Rev.2. MAHs and assessors are facing the challenge to apply the revised definition across different countries and for different products. Furthermore, the revised GVP definition does not apply to the PSUR. There is no unambiguous guidance on how to categorise safety concerns in the PSUR that have been removed from the RMP. This lecture will present the implications of the GVP revision for the management of safety concerns worldwide, highlighting the challenges of preparing RMPs and PSURs from an industry perspective.

Tiziana von Bruchhausen Tiziana von Bruchhausen – Senior Pharmacovigilance Writer at Boehringer Ingelheim

In 2018, to further improve harmonisation of the safety concerns in the Risk Management Plans (RMPs), the Working Party on Pharmacovigilance Procedures Work Sharing initiated the so-called Harmonisation of RMP Project (“HaRP”). The aim of HaRP is to harmonise List of safety concerns for the same active substances with RMPs in place, for which marketing authorisations have already been granted.

First review and harmonisation of the list of safety concerns is performed by the HaRP peer review group and is based on those RMPs published on the Excel list. Following this initial review, in a subsequent consultation round, feedback is asked from Pharmaceutical Industry and all Member States. Final assessment of the revised list of safety concerns and additional pharmacovigilance activities or additional risk minimisation measures per substance will be sent to CMDh for final adoption.

This presentation gives an overview about the background of HaRP, the underlying methodology and presents actual HaRP assessment reports.

Nicole Bick Nicole Bick – Safety and Pharmacovigilance Expert

Scientific Board

Boris Thurisch
Boris Thurisch Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association
Tiziana von Bruchhausen
Tiziana von Bruchhausen Senior Pharmacovigilance Writer at Boehringer Ingelheim

Speakers

Nicole Bick
Nicole Bick Safety and Pharmacovigilance Expert
Monika Borchert
Monika Borchert Deputy EU-QPPV Head at Novartis
Boris Thurisch
Boris Thurisch Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association
Ulrich Vogel
Ulrich Vogel Head of Strategic Data Analysis at Boehringer Ingelheim International
Tiziana von Bruchhausen
Tiziana von Bruchhausen Senior Pharmacovigilance Writer at Boehringer Ingelheim
Eva-Maria Westphal
Eva-Maria Westphal Associate Director and Engagement Manager (Pharmacovigilance), Global Tech Solutions, IQVIA

Scientific Board

Boris Thurisch
Boris Thurisch Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association
Tiziana von Bruchhausen
Tiziana von Bruchhausen Senior Pharmacovigilance Writer at Boehringer Ingelheim

Conference Venue

German Pharmacovigilance Day Virtual

4 hours live conference, divided in 2 sessions (morning and afternoon), with slots for Q&A and discussion among delegates.




Useful information

LS Academy will provide the link to join the conference some days before the event date.


Fee includes: access to the virtual live event, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.



Useful numbers

Francesca Archetti
Francesca Archetti Operations & Training Manager
Annalisa De Biasi
Annalisa De Biasi Project & Scientific Manager
Enrico Pedroni
Enrico Pedroni Managing Director

Past Events

Conference Price

420.00 €

Early Bird

Sunday, May 3, 2020

360.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

For information:

Contacts:

Francesca Archetti
Francesca Archetti Operations & Training Manager
Annalisa De Biasi
Annalisa De Biasi Project & Scientific Manager
Enrico Pedroni
Enrico Pedroni Managing Director
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Participants' Feedbacks

Perfect opportunity to have "hot topics" to discuss outside the"own environnment". Opportunity to have several topics discussing in just one day 

Very competent board! It was actually nice that we were not more than approx. 70 people, the dialog and networking in this setting was really good.

Good speaker portfolio; Broad pv topic spread

Good mixture of speakers

Excellent platform for exchange of experience and learining

Thank you very much for all organizing efforts and for an excellent conference

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The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
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