Introduzione

Pharmacovigilance Today: Back to Business!

Pharmacovigilance has been under unprecedented stress from a worldwide pandemic situation causing fundamental challenges and changes to its operations and not least to the availability of the PV professionals to fulfill existing and new roles. Underneath all these new world-changing demands lie the ever-demanding challenges of adapting the pharmacovigilance systems and operations to a globally diverse regulatory environment, like implementation of a new Clinical Trial Regulation, a new Medical Device legislation, technological advancements, automations and a new Eudravigilance implementation of the ISO/ICH E2B(R3) ICSR standard and guideline.
The pharmacovigilance landscape is subject to change and this calls for bringing PV professionals together to share views, concerns, challenges, and experiences of the matters that happen in the PV and regulatory environment.

In this conference you will not only hear from the experts, but we will stimulate interaction amongst the audience to learn from each other. We all cope with similar company and regulatory challenges, so why not learn from each other?

The fourth edition of the International Pharmacovigilance Day, organized by LS Academy, will be a really interactive conference and it will focus on the following topics, among others:

- Implementation of the EU CTR / CTIS
- Local pharmacovigilance: the link between Headquarter and affiliates
- Non-EU PSMFs and QPPVs: best practices
- Evolving PV landscape in times of pandemic
- Social media monitoring
- Mergers and acquisitions: PV system integrations
- PV audits and inspections
- QMS and relevant KPIs
- Risk management: digital vs paper materials
- PV Technologies and automations

Don’t miss the opportunity to update your knowledge, collect new contacts and discuss with other PV professionals coming from all over Europe.
It will be a pleasure to meet each other in Madrid on September 12th and 13th, 2022.

Scientific Board

  • Martijn van de Leur, Head of Global PV at Biomapas (Chair of the Scientific Board)
  • Martijn Dahlhaus, Head of Country PV, WorldWide Patient Safety at Bristol-Myers Squibb
  • Jørgen Matz, Head of Global Pharmacovigilance & Drug Safety, EU QPPV at InsudPharma

 

Who should attend?

The conference program is designed for healthcare professionals or pharmacists in safety surveillance 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, sponsors, vendors and CROs, representatives from patient organizations.

Programma

Please note that timings and topics can be subject to change

Draft programme updated daily, more details available soon

12 September 2022
13:30
14:00
Registration
14:00
14:15
Welcome Day 1
14:15
14:55
Implementation of the EU CTR / CTIS: Initial experiences, opportunities and challenges
Christel Gremion Viatte - Global regulatory CTA Team Lead, Associate Director at CSL Behring

Abstract available soon

14:55
15:35
Non-EU PSMFs/QPPVs: Best practices
Nina Sagbana - International Deputy QPPV at Vifor Pharma
José Torres Fuenzalida - Regional QPPV for Latin America (LATAM) Region at Vifor Pharma
Ashraf Megahed - Regional QPPV MENA at Vifor Pharma

The rapid globalization of good Pharmacovigilance Practices (GVP) has resulted in regulatory authorities expanding the level of their pharmacovigilance (PV) requirements to align with the existing European Union Good Pharmacovigilance Practices (EU GVP). These requirements include the Pharmacovigilance System Master File (PSMF) tailored to meet individual country/regional specific requirements.

Since the introduction of the EU GVP Module II guidance in 2012, which provided a framework that allowed varying organizational structures of marketing authorization holders (MAHs), the concept of the PSMF has evolved in countries/regions outside of the EU over the years, creating challenges related to maintenance and production of a PSMF (local or regional). It is therefore imperative that processes are put in place to overcome these challenges because through the production and maintenance of the PSMF, be it local or regional, the MAH and the non-EU local/regional QPPV should be able to verify if the PV system has been implemented in accordance with specified regulatory requirements and compliance.

As more and more health authorities/regulators both in and outside the EU increasingly expect the QPPVs to have oversight of all activities impacting PV, not just core PV activities, It is important to note that a compliant PV system requires effective interfaces with various stakeholders. E.g., regulatory affairs, quality assurance, product quality, medical information, etc. Hence, the QPPV must implement best practices to ensure adequate oversight of the PV system under their responsibility.

For regions outside the EU, e.g.  Latin America (LATAM) and the Arab region, the alignment of the local/regional PSMF with company`s EU or global PSMF is essential to ensure consistent information is delivered to regulatory agencies/inspectors globally. Also, this alignment will enable the non-EU local/regional QPPVs have adequate oversight of their local/regional PV systems and awareness of any updates on the global PV system that impacts the non-EU PV systems.

15:35
16:05
Coffee Break
16:05
16:45
PV audits and inspections: Trends and developments
Ranjana Khanna - Director Global QA Pharmacovigilance at Nestle Health Science

In the early 1990’s, mostly GCP and GMP inspections included aspects of Pharmacovigilance such as SAE management and associated activities. Although Pharmaceutical Companies were constantly preparing for PV Inspections, Health Authorities conducted limited Pharmacovigilance inspections which were mostly for new approvals or for-cause. With the coming of Volume 9A, systematic inspection programs were triggered by some Health Authorities (HA) such as ANSM (France), MHRA (UK), AIFA (Italy). MHRA then put in place a risk assessment questionnaire that pharmaceutical companies were expected to complete, those who did not complete were automatically on a higher inspection risk. Based on the analysis, MHRA conducted routine inspections mostly every three years, of course triggered inspections were also conducted. Other Health Authorities still conducted limited Inspections due to limited internal resources and training. The FDA did conduct CDER inspections under its BIMO Compliance programs. In Australia, Middle-East, LATAM, and Eurasia PV inspections were still not being conducted.
With the coming of the GVP in 2012, and the roll-out of Module III the Inspection conduct in the EU intensified. Obligations were laid out not just to MAH’s but also to the national Health Authorities expecting them to have detailed inspection programs, the types of inspections were better defined into routine/ for cause, pre-post authorisations, announced/ unannounced, re-inspections etc. EMA, PRAC, CHMP, European Commission also took a central role in Inspections working together with the national HA’s. The Rest of world followed, with implementing the GVP in Arab Countries, Eurasia, and countries like Japan (PMDA) and Australia (TGA), Health Canada also setup their Inspection programs. Several national European Health authorities started to systematically roll out questionnaires to pharmaceutical companies to help them make a risk assessment for their Inspection program such as ANSM, BfArM (Germany), IGJ (Netherlands), OGYEI (Hungary) etc. PV Inspections in the USA were defined as Post marketing drug experience (PADE) focusing on standard PV topics of case collection or Risk Evaluation and Mitigation Strategies (REMS) Inspections focusing on risk minimization or mitigation activities laid out during drug approval.
Over time, the kind of inspections being conducted has changed. E.g. MHRA now has a revised inspection model with four types of Inspections: Routine PV, Routine risk management and safety communication, additional risk minimization measures (aRMMs) and Non-Interventional PASS. The COVID 19 pandemic also influenced remote Inspection conduct. Currently Inspections are done either remotely, on-site or a mix of both. Inspection findings are now shared by HA’s with each other and metrics and trends are shared with the public.
In the past, limited Pharmacovigilance audits were conducted by pharmaceutical companies, mostly of the vendors who undertook key tasks in case management etc. Although, Vol 9A had some requirements clearly stated for conduct of PV Audits, the requirements for a risk-based audit program with an audit strategy and tactical and operational planning for audits kickstarted with coming of GVP Module I and IV. Pharmaceutical companies in Europe then setup a PV audit universe defining clear entities for audits (vendors, systems, partners, affiliates, IT systems, special programs) and conducted an ongoing and annual analysis based on risk criteria for the various entities.
Over time however additional entities have been included into the audit universe such as for a PASS program the tool and systems, vendor, site, documents also need to be audited. Market research vendors, or vendors managing patient assistant programs now form a part of the audit universe and must be audited.
Companies have been required to setup separate units within Quality assurance for PV audits and a resource pool of trained PV auditors needs to be developed.
The type of findings identified has also matured over the years. Although typical case processing related findings (collection, reporting, follow-up, pregnancy) are still identified, observations related to reference safety information management, risk effectiveness checks and minimization measures are seen more and more. Quality management system associated gaps continue to be seen in procedures, audits and CAPA management. The differences in legislation between countries has also been a challenge for pharmaceutical companies to implement a harmonized process across the organization, so one size does not fit all.

16:45
17:05
KPIs for optimal quality control – The perspectives and expectances from a QA point of view
Ruth López Magdaleno - Clinical & Pharmacovigilance Quality Manager at InsudPharma

Abstract available soon

17:05
17:25
The challenging exercise of maintaining overview via KPIs from a PV point of view
Jørgen Matz - Head of Global Pharmacovigilance & Drug Safety at InsudPharma

Abstract available soon

17:25
17:30
Conclusions Day 1
13 September 2022
09:30
09:40
Welcome Day 2
09:40
10:20
Different types of non-Pharmacovigilance Vigilance: An Overview
Olga Asimaki - International QPPV at Biomapas

Have you ever thought that the International Pharmacovigilance Day could also be International (Pharmaco)vigilance or even International Vigilance Day?
The purpose of this presentation is not to change the scope of the conference, but to further broaden the horizon of vigilance to other product safety categories.
Pharmacovigilance is responsible for monitoring the safety of medicinal products for human use. But is it the safety of medicines only that should be monitored and assessed? Can’t humans or other animal species gain benefit or be harmed by non-medicinal products?
Hence, the primary concern is again about safety. Medical devices, diagnostics and Healthcare IT (Materiovigilance), cosmetics (Cosmetovigilance), food supplements and nutritional products (Nutrivigilance), and animals’ drug safety (Veterinary pharmacovigilance) are nowadays well-regulated although they are subject to a different regime than medicinal products. The basic principle of these types of vigilance is still ensuring a safe use of product, updating information and taking all measures required so that this never fails. However, there are several differences between the surveillance expected for medicinal products intended for human use versus a veterinary drug as well as between medicinal products and non-medicinal ones. Even vaccines and biologics, a diverse group of medicines, are governed by specific requirements.
The presentation will summarize the basic requirements that a company needs to meet for all its products on the market to ensure safety and compliance, and reduce risks.

10:20
11:00
Local pharmacovigilance: The link between affiliates and headquarter
Martijn Dahlhaus - Head of Country Pharmacovigilance at Bristol Myers Squibb

Abstract available soon

11:00
11:40
Risk management: Digital VS paper materials
Bart Van Den Bemt - Professor in Personalized Pharmaceutical Care at UMC St Radboud and Pharmacist/Clinical scientist/Medical Manager at Sint Maartenskliniek

Abstract available soon

11:40
12:10
Coffee Break
12:10
12:40
INTERACTIVE SESSION: Discussion in groups on selected topics (Part 1)

During this interactive session, participants will be divided in groups and will have the possibility to discuss about one specific topic, guided by an expert chair. After 30 minutes, groups will change and face a different subject.

The list of topics will be announced soon.

At the end of the discussion, everybody will come back to the plenary session and each moderator will sum up the main points suggested by the groups.

12:40
13:10
INTERACTIVE SESSION: Discussion in groups on selected topics (Part 2)
13:10
13:40
Feedback from the interactive session
13:40
14:40
Networking Lunch
14:40
15:20
Pharmacovigilance in 10 years: a vision on its evolvement
Martin Huber - Safety and pharmacovigilance expert

This year we are looking back to 10 years of experience with the so-called pharmacovigilance legislation that came into force 2012. The world of pharmacovigilance has substantially changed since that time, and will further evolve in the future. It is time to take stock and to reflect upon how pharmacovigilance would or should look like in 10 years from now. Promising developments are ongoing as regards the availability of big data with advanced analytical approaches or new technologies including artificial intelligence. They will become important tools in pharmacovigilance in the near future but the question remains whether they are to be considered real game changers.
New opportunities in terms of technical advancements will require the adaptation of the regulatory framework including the legislation, not only in Europe but also from a global perspective. Collaboration will be key – between regulators, industry and other stakeholders including academia, but also between the European regulatory network and the rest of the world. Last but not least the pandemic has shown both the strength of the current system and the challenges we are all facing. It is therefore essential to benefit from the lessons learnt to be prepared for any future scenario.

15:20
15:50
Interactive PV Quiz
15:50
16:00
Conclusions Day 2
16:00
16:30
Final Coffee Break
Relatori
Martijn van de Leur
Info Scientific Board

Martijn van de Leur

Head of Global Pharmacovigilance at Biomapas
Martijn van de Leur has over 16 years of experience in pharmacovigilance. Martijn van de Leur graduated from Radboud University as a Biomedical Scientist with specializations in Pathobiology and Oncology. Since 2005, he started to work in the life science industry, concentrating in the pharmacovigilance area. As a senior leader in pharmacovigilance and experienced (Deputy) EU QPPV, Martijn has a broad network within the industry and is a known industry speaker with excellent drug safety experience. Before joining Biomapas, he acted as Global Head of Drug Safety Compliance and Global Head of Drug Safety Technologies at Vifor Pharma, and further back in his career working as Pharmacovigilance Lead at Merck.
Martijn Dahlhaus
Info Scientific Board

Martijn Dahlhaus

Head of Country Pharmacovigilance at Bristol Myers Squibb
Martijn Dahlhaus is Head of Country Pharmacovigilance in The Netherlands at Bristol Myers Squibb. Heading the local pharmacovigilance organisation, he carries responsibility for all pharmacovigilance and risk management activities in The Netherlands and has regularly and successfully hosted PV audits. He is also deputy for Belgium and Luxembourg. Martijn has been in this role for the past 9 years, before which he held various roles in Pharmacovigilance and Medical Information at Genzyme and Novartis.  Martijn is an ACRP-certified CRA and holds a Master’s degree in Medical Biology and a PhD in Neurobiology, both from the Vrije Universiteit in Amsterdam, Netherlands.  
Jørgen Matz
Info Scientific Board

Jørgen Matz

Head of Global Pharmacovigilance & Drug Safety at InsudPharma
Jørgen Matz, MSc, PhD, PgD is the Head of Global Pharmacovigilance & Drug Safety for InsudPharma in Madrid, which is a healthcare company with business units for worldwide manufacturing, development, and marketing of branded, generic and biotechnological products. Jorgen Matz has been in the pharmaceutical industry for about 25 years, hereof 15 years in Global Pharmacovigilance & Drug Safety. He has a background as an experimental pharmacologist and his focus areas in recent year has been on implementing pharmacovigilance systems tailored to support ICSR processing and continuous benefit-risk assessments of marketed products.
Martin Huber
Info Speaker

Martin Huber

Safety and pharmacovigilance expert
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.
Ranjana Khanna
Info Speaker

Ranjana Khanna

Director Global QA Pharmacovigilance at Nestle Health Science
Ranjana Khanna has been working in the field of Pharmacovigilance since 2004, first in Case Operations and then in Quality Assurance with at least 10 years as Head PV QA. She has a Master’s in Technology from IIT, India and has completed a Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire, UK. Ranjana has experience of working in a CRO, and in pharmaceutical companies. In her role she conducts audits, leads Inspections, provides trainings, and supports in day-to-day guidance relating to PV tasks such as developing processes. Having led several HA Inspections including MHRA, FDA, TGA, Health Canada and EMA, she has conducted over a 100 PV audits in about 50 countries and is familiar with legislative requirements, and industry best practices.
Ashraf Megahed
Info Speaker

Ashraf Megahed

Regional QPPV MENA at Vifor Pharma
Ashraf Megahed holds a Bachelor of Science in Pharmaceutical Science from the University of Tanta Egypt, a Graduate Certificate clinical and Drug Development university of New South Wales Australia and a Graduate Certificate Clinical Pharmacy Queen’s University Belfast Ireland. With over 30 years’ experience in the pharmaceutical industry, in his last role, he worked in Aspen Healthcare as MENA Regional QPPV & Quality Manager to setup the local quality Management system and the local Pharmacovigilance system until his current role. Ashraf Megahed is currently the Regional QPPV for the Arab region markets and Iran.  He is responsible of establishing and maintaining/managing the company's pharmacovigilance system in Arab Region. He maintains Local PSSF and oversight over all delegated tasks and the entire Local pharmacovigilance system.  Personally, responsible for the safety of the products marketed by Vifor Pharma so he has an overview of the safety profiles and any emerging safety concerns for the company's products.
Nina Sagbana
Info Speaker

Nina Sagbana

International Deputy QPPV at Vifor Pharma
Nina Sagbana holds a Bachelor of Science in Pharmaceutical Science from the University of North London, the UK, and a master’s in Environmental Technology from Imperial College London, UK. She began her career in the pharmaceutical industry with GSK in 2002 as a clinical coding specialist in data management and transitioned to pharmacovigilance in 2004. With over 17 years’ experience in the pharmaceutical industry, in her last two roles, she worked in Roche as a consultant International PV Leader for EEMEA and at Syneos Health, as the Associate Director Safety & PV responsible for the setup of the local PV networks until her current role. Nina Sagbana is currently the International Deputy QPPV at Vifor Pharma based in Zurich, Switzerland. She is responsible for the oversight of pharmacovigilance activities in the non-EU countries/regions, as well as PV intelligence within Vifor’s global PV organization. As part of her operational activities, she is also a reviewer of Vifor Pharma Pharmacovigilance System Master File (PSMF) and provides guidance to Regional and local QPPVs on the creation of PV Sub-System Files (PSSF).
José Torres Fuenzalida
Info Speaker

José Torres Fuenzalida

Regional QPPV for Latin America (LATAM) Region at Vifor Pharma
Jose Torres Fuenzalida holds a Master of Sciences in Biology and a PhD in Biology from the National University of Buenos Aires, Argentina. He began his career as a basic science researcher in the Liver Stem Cells field. After 10 years in research, he decided to move to the pharmaceutical industry. He joined Cognizant Technologies Solutions as a Safety Data Analyst in 2011 and, in 2013, he was promoted to PV Team Leader. In 2015 he received the opportunity to join the National Health Authority in Argentina (A.N.M.A.T.) as Advanced Therapies Medicinal Products Leader and, in 2017, he was promoted to Chief of the Department of Biological Products in the same institution. Jose Torres Fuenzalida is currently the Regional QPPV for Latin America (LATAM) Region at Vifor Pharma based in Buenos Aires, Argentina. He is responsible for the oversight of pharmacovigilance activities performed by the commercial partners in LATAM region. As part of his regular activities, he provides PV training and shares best practices with commercial partners.
Bart Van Den Bemt
Info Speaker

Bart Van Den Bemt

Professor in Personalized Pharmaceutical Care at UMC St Radboud and Pharmacist/Clinical scientist/Medical Manager at Sint Maartenskliniek
Biography available soon
Olga Asimaki
Info Speaker

Olga Asimaki

International QPPV at Biomapas
Olga Asimaki is a certified Medical Affairs professional experienced in Pharmacovigilance and Medical Information activities. After Olga decided to move to the pharmaceutical sector leaving Academia and Research, she started her career in Pharmacovigilance in Zencro, a European CRO, and later moved to large Pharma for over 7 years as Head of Pharmacovigilance and Medical Information at AbbVie. Olga has extensive experience in all aspects of Pharmacovigilance, leading and developing PV teams and local PV systems. Additionally, Olga has successfully led the PV function through audits and inspections and driven a plethora of global projects and initiatives. With regard to Medical Information, she worked with AbbVie’s global teams to successfully launch and implement a global Medical Information system and processes. Currently, as International QPPV in Biomapas, Olga is leading the QPPV Office, and overseeing the global network of Regional QPPVs and the Full PV activities executed by Biomapas. Olga is a post-doctoral Neuroscientist holding an MSc from King’s College London and a PhD in Pharmacology (BRFAA / School of Medicine, University of Thessaly). After joining the industry, Olga obtained an official certification from King’s College/IFAPP in Medicines Development.
Ruth López Magdaleno
Info Speaker

Ruth López Magdaleno

Clinical & Pharmacovigilance Quality Manager at InsudPharma
Ruth López Magdaleno is the Clinical and Pharmacovigilance Quality Manager for Insud Pharma in Madrid, which is a healthcare company with business units for worldwide manufacturing, development, and marketing of branded, generic and biotechnological products. Ruth López Magdaleno works in Pharma Industry since 2001, majority of the time in Clinical Operation Departments changing into a Quality Department in 2015. She has a big experience implementing systems across the different business units and countries, leading and hosting GCP and GVP audits and inspections across de World.  
Christel Gremion Viatte
Info Speaker

Christel Gremion Viatte

Global regulatory CTA Team Lead, Associate Director at CSL Behring
Christel Gremion Viatte leads currently the Global Regulatory Affairs CTA group at CSL Behring. She has 16 years experience in management of global clinical trials and in development of clinical trials regulatory strategy. For the EU Clinical Trial Regulation EU536/2014 she was involved in early testing of the CTIS submission portal and contributed as sponsor representative to EMA stakeholder readiness activities. Since several years, she is actively involved in the workstream getting CSL Behring ready for this regulation. Christel holds a PhD in Immunology and a Regulatory Affairs Certificate in Pharmaceuticals and Medical Devices from the RAPS University.
Contatti

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

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


Quote di iscrizione

€ 945,00*      Super Early Bird fee until 12 June 2022
€ 980,00*      Early Bird fee until 12 August 2022
€ 1.190,00*   Ordinary fee
€ 730,00*      Freelance, Academy, Public Administration

* for Italian companies: +22% VAT

Fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, 1 networking lunch, 3 coffee breaks, organisational office assistance, certificate of attendance.


Informazioni utili

The conference will take place at:

Hotel H10 Puerta de Alcalà
C/ Alcalá, 66 – E28009 – Madrid

The hotel is located near El Retiro Park, in Madrid’s Salamanca district.

Metro Príncipe de Vergara L2, L9: 120 m
Metro Velázquez L4: 500 m
Centro ciudad · City centre: 1,7 km
Aeropuerto · Airport: 11 km

Edizioni Passate
2021
Evolvement of Pharmacovigilance Today and in the Near Future
2020
A Global Pharmacovigilance Network: Opportunities and Challenges
2019
Pharmacovigilance Within and Without Borders
Diventa Sponsor Versione Stampabile
<p style="text-align: center;"><strong>Hotel H10 Puerta de Alcalà</strong><br />
C/ Alcalá, 66<br />
E28009 &#8211; Madrid</p>

Hotel H10 Puerta de Alcalà
C/ Alcalá, 66
E28009 – Madrid

<p style="text-align: center;"><strong>Hotel H10 Puerta de Alcalà</strong><br />
C/ Alcalá, 66<br />
E28009 &#8211; Madrid</p>
<p style="text-align: center;"><strong>Hotel H10 Puerta de Alcalà</strong><br />
C/ Alcalá, 66<br />
E28009 &#8211; Madrid</p>
<p style="text-align: center;"><strong>Hotel H10 Puerta de Alcalà</strong><br />
C/ Alcalá, 66<br />
E28009 &#8211; Madrid</p>

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