About

Evolvement of Pharmacovigilance Today and in the Near Future

Pharmacovigilance is ‘hotter’ than ever. A simple search on Social Media can give a good idea of the impact of pandemic on Pharmacovigilance. How the perceptions of clinical research, drug approval and adverse events among the public have evolved; adaptations to the regulatory framework to address challenges arising from the current situation; and the change to the way that ‘PV people’ work.

At the same time, Brexit and implementation of the new regulatory base of pharmacovigilance in the UK, as well as in the Eurasian Economic Union (EAEU) countries, have transformed Pharmacovigilance to a key element brought to the attention of all pharmaceutical industry players. For years, a globally harmonized approach to Pharmacovigilance has been discussed as a concept for integrated regulations. Considering the recent developments, are we Getting Closer or Further Away from Harmonized systems?

The third edition of the International Pharmacovigilance Days, organized by LS Academy, will focus on all these topics, among others:

  • What are the points to be considered when a PV system is set up outside the EU?
  • What are the inspection and quality aspects challenges under the new Legislation Era?
  • Is a transition from an EU-QPPV Office to International QPPV Office required?
  • How has the COVID-19 affected the digital transformation of PV? Is this ‘new way we work’ here to stay?
  • PV Technologies reality check – where do we stand? Are the promises of technology coming true?
  • Are new PV business models required to meet current and future needs? Pharmacovigilance outsourcing and vendor oversight – what are the trends and best practices?
  • Current discussions for accelerated drug approval and safety monitoring: Will they have a further impact on patients’ involvement on drug development?

Register to attend this 5-day event that will be held online from June 14th to June 18th 2021.

 

Scientific Coordinator
Biomapas’ Pharmacovigilance Team

Who should attend?
The event is designed for professionals in the field of Pharmacovigilance from Pharmaceutical Industry, CROs, Patient Associations and Healthcare Organizations, Regulatory Authorities.

 

For any further information, and sponsorship opportunities contact us info@lsacademy.com

Programme

The conference will be divided in 5 virtual appointments from 14th to 18th June (afternoon CEST – 2,5 hours each).

The Agenda will cover 3 main macro-areas:

  • Globalization of Pharmacovigilance: Getting Closer or Further Away from Harmonized Systems?
  • Pharmacovigilance System: Best Practices and Case Studies
  • Patient Involvement in Drug Development and Vaccines

We are working on the programme and it will be updated day by day, with speakers’ names and new abstracts.

All the below mentioned times are CEST 

 

14 June 2021
2.30 pm
2.45 pm
Welcome Day 1
2.45 pm
3.20 pm
Transition from EU-QPPV office to International QPPV Office
Nina Sagbana - International Deputy QPPV at Vifor Pharma

The internationalization of Good Vigilance Practice (GVP) i.e. adoption of the GVP by several countries/regions has led to local/regional GVP legislation largely based on EU PV regulations. As a result of this, there is a need for a transition from the EU QPPV office to International QPPV office for oversight of the safety profiles of a company’s medicinal products and any emerging safety concerns, and coordinate communication to competent authorities.

A look at the current COVID-19 vaccination programs around the world which have resulted in the identification of certain vaccine safety-related issues also presents an ideal scenario for transition from the EU QPPV office to International QPPV office in the pharmaceutical industry. Identified safety issues are likely to have a global impact with possible consequences as more and more health authorities around the world collaborate to assess the benefit-risk balance of medicinal products. In addition, regional PV systems need to be implemented or updated and oversight mechanisms implemented. The role of the QPPV office in an organization will no longer be focused on the EU only as a cohesive international assessment and response is now required.

3.20 pm
3.55 pm
From EU to International PSMF
Willemijn van der Spuij - Executive Director Europe, Patient Safety at Bristol Myers Squibb

The presentation will explore the evolution of the PSMF since its introduction in the EU and its subsequent implementation in many other countries and regions: The current global PSMF landscape and requirements will be presented and challenges across the world will be considered; how manage a global document that is subject to local requirements and regulators review.

Practical solutions to simplify work will be explored through the discussion of an expert paper developed by a small expert group.

3.55 pm
4.10 pm
Coffee Break
4.10 pm
4.45 pm
Inspection and Quality Aspects' Challenges under the new Legislation Era
Ranjana Khanna - Head of Pharmacovigilance Quality Assurance at Vifor Pharma

The 2012 GVP legislation brought a big change in the quality expectations relevant for Pharmacovigilance activities. Previously PV tasks included quality aspects that were an adaptation from GCP and GMP legislation. Stringent requirements related to quality processes, training, auditing and associated topics such as deviation and CAPA management needed to be implemented. Pharmaceutical companies were required to streamline processes and setup new departments such as PV QA to meet the expectations. Dedicated PV staff were trained to successfully implement the quality requirements of the legislation.

Post GVP roll out era, EU Health authorities have shifted the focus in their inspections to the quality requirements laid out in the legislation. An almost 30% weightage is given to quality topics in the interviews and document reviews. From developing the risk based audit universe for PV and considering all interfaces, be it Market research vendors or PASS programmes: inspectors review the critical risk factors used to develop the annual audit programme ensuring the judgement made by the company is focusing on patient safety. The implementation of corrective actions and their effectiveness checks need to be demonstrable.

Slowly other countries that have followed Europe’s footsteps in implementing the GVP, like Australia or Eurasian Union are also paying great emphasis to the PV quality standards followed by the companies. In this presentation, Ranjana shares some challenges seen in her many years of experience in GVP audits and inspections.

4.45 pm
5.00 pm
Conclusion Day 1
15 June 2021
2.00 pm
2.15 pm
Welcome Day 2
2.15 pm
3.15 pm
Roundtable | GVP-like legislation outside Europe: overlap and differences
Lidia Maksyutkina - Regional Pharmacovigilance Manager, Russia and CIS at Biomapas
Mina George Awad - Pharmacovigilance Manager and QPPV, Middle East at Kyowa Kirin International
J Vijay Venkatraman - Managing Director & CEO at Oviya MedSafe

With the ever-expanding PV legislations worldwide, many countries and regions choose to adopt rules that are comparable to European Union’s Good Pharmacovigilance Practice (GVP) modules, but not always necessarily 100% the same.

For example: when operating in countries in Middle East/North Africa the Arab GVP applies, and when operating in Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan, the EAEU GVP applies. In addition, there may be specific national requirements or other local expectations.

In this roundtable, we start from our European angle and will discuss with QPPVs from EAEU and Arab regions what the regional differences and stages of implementation are, and what this means in practice.

We will have both Indian and UK points of view as well.

And we ask for your questions and suggestions too!

3.15 pm
3.30 pm
Roundtable Q&A and Discussion
3.30 pm
3.45 pm
Coffee Break
3.45 pm
4.20 pm
Establish PV systems in USA: Points to consider
Kristina Keeler - Senior Director of Global Safety Operations at Drug Safety Navigator (DSN)

Building and launching a high-performing PV system in the US that meets the strict standards for regulatory compliance requires extensive planning. There are several points to consider when establishing your PV system including managing PV vendors, understanding unique FDA requirements, and utilizing marketing data (sales force roll out, drug distribution, patient assistance programs, marketing partners, etc.) to ensure appropriate PV budgeted activities are in place.

DSN shares key best practices for success that the team has learned through first-hand experience on numerous PV engagements in the US.

4.20 pm
4.30 pm
Conclusion Day 2
16 June 2021
2.00 pm
2.15 pm
Welcome Day 3
2.15 pm
2.50 pm
Distributed database network for post-marketing surveillance of drugs: the Italian experience
Gianluca Trifirò - Full Professor of Pharmacology at University of Verona

Large volume of electronic healthcare data is increasingly available worldwide and many healthcare databases have been already used since decade to address questions regarding pattern of use, safety and effectiveness of medicines in real world setting.

In several Countries, distributed database networks have been created with the final goal to support informed drug regulatory decision making. Examples include FDA endorsed Sentinel and Canadian CNODES which allows scientific community in synergy with national regulatory agency to rapidly address research questions concerning real world use of drugs by accessing and analysing large scale healthcare data infrastructure generally adopting common data model (CDM).

Italy is also rich of healthcare databases and a number of projects have been funded to set up data infrastructure through linkage of different Regional claims databases and clinical registries using ad hoc CDM for post-marketing surveillance of specific medicines (e.g. biologics) and populations (post-transplant patients or those with autoimmune disease).

In this presentation, strategies for developing such distributed database networks as well as potential and limitations for post-marketing surveillance of drugs using this large scale data infrastructures will be in general discussed and practical applications from Italy will be specifically presented.

2.50 pm
3.25 pm
Oversight of PV System: Quality Parameters and KPIs
Marie-Charbel El Chalouhi - International Pharmacovigilance Operational Excellence at AbbVie

Abstract available soon

3.25 pm
3.40 pm
Coffee Break
3.40 pm
4.15 pm
Pharmacovigilance outsourcing and vendor oversight
Bert van Leeuwen - Deputy Qualified Person for Pharmacovigilance (QPPV) at Astellas Pharma Europe

Abstract available soon

4.15 pm
4.30 pm
Conclusion Day 3
17 June 2021
2.00 pm
2.15 pm
Welcome Day 4
2.15 pm
2.50 pm
Black spots in an end to end digital platform project: the non-technical considerations
Claudia Lehmann - Vice President of Global Patient Safety & Pharmacovigilance Operations & Systems at Boehringer Ingelheim

While we tend to focus on functionality, performance, security, architecture etc. in a technical project of implementing an end to end digital platform for PV operations, the introduction of automation at a large scale must not neglect topics such as the general intent of why we introduce the platform, the process revamp from manual to digital and of course change management with everyone involved, including users and partners in the end to end process.

The presentation will address many of these factors and share guiding principles for decision making around many of the steps. Personal learnings will be discussed, and some examples will be shared.

2.50 pm
3.25 pm
Artificial Intelligence for conversation automation
Laimonas Sutkus - Chief Technology Officer at Biomapas

The information explosion in the pharma industry has not only created new challenges but also created new opportunities. The most clearly seen opportunity is the most data-hungry one – the A.I.-based automation. We will discuss one of the most complex A.I. fields – the Natural Language Processing field and its potential to automate conversations in the pharma industry e.g. Medical Information. We will touch on the challenges, use cases, benefits, existing solutions and new solutions

3.25 pm
3.40 pm
Coffee Break
3.40 pm
4.15 pm
Effect of Covid-19 situation on digital transformation
Richard Wolf - Executive Director, Pv Operations Head in the Global Clinical Safety and Pharmacovigilance group at CSL Behring

Covid 19 has driven impacts in many different areas, and Pv is no exception.  During this session we’ll discuss the pragmatic impacts impacting day to day work, as well as some unanticipated and positive impacts that have driven performance improvement across this space as well as rapid uptake of certain aspects of the digital transformation.

4.15 pm
4.30 pm
Conclusion Day 4
18 June 2021
2.00 pm
2.15 pm
Welcome Day 5
2.15 pm
2.50 pm
Safety aspects of Covid-19 vaccines
Alex Bica - Director, Clinical Safety Physician, Department Global Clinical Safety and Pharmacovigilance at CSL Behring

Covid-19, the first alarming pandemic of the third millennium, has caused global public health and economic crises, necessitating rapid development of vaccines. The world-wide response has been unprecedented with government, academic, and private partnerships working together, rapidly exchanging information and ultimately changing the traditional, lengthy approaches in vaccinology with new emerging technologies offering a promising solution for a faster and more flexible development of vaccine candidates that will positively change the global pandemic preparedness strategy.

The monitoring of adverse reactions associated with vaccination is one of the most important factors in vaccine safety. Although vaccines are among the safest medicines on the market, vaccines are not completely risk-free, and adverse events may occur following vaccination. Careful assessment of any adverse events following immunisation is essential to distinguish those that are causally linked to the vaccination from those just coincident in time, in order to prevent vaccine distrust or misperception and to ensure an efficient vaccination campaign especially in the context of a global pandemic.

The objective of this presentation is to critically review the most up to date available safety data on different Covid-19 vaccine candidates, understanding their specifications from the mode of action to effectiveness in the context of a challenging global vaccination campaign.

2.50 pm
3.25 pm
Topic to be announced
Speaker to be announced - Biography available soon
3.25 pm
3.40 pm
Coffee Break
3.40 pm
4.15 pm
Topic to be announced
Speaker to be announced - Biography available soon
4.15 pm
4.30 pm
Conclusion Day 5
Speakers
Martijn van de Leur
Info Scientific Board

Martijn van de Leur

Head of Global Pharmacovigilance at Biomapas
While working in the industry for over 15 years Martijn has experienced many different roles in pharmacovigilance. Growing from entry level positions in safety data management to senior medical advisory roles within the Clinical Risk Management teams, Martijn helped his companies to develop their PV systems through multiple massive company merger integration projects. From Organon to Schering-Plough, followed by an integration into Merck Sharp & Dohme (MSD), he was deeply involved in the challenges of merging massive PV databases, integrating highly complicated SOP systems, and unifying PV processes in international pharmacovigilance. In his last role at MSD, he had a pivotal role in aligning case management processes and providing PV trainings worldwide. Later, after joining Vifor Pharma, Martijn was in executive roles as (Deputy) EU QPPV, establishing also the Global PV Compliance and PV Technologies teams. In early 2020, Martijn joined Biomapas as Head of Global Pharmacovigilance, leading the PV department in Lithuania and worldwide. Biomapas is a functional and full outsourcing solution provider to the global life science industry. Besides their key expertise in Clinical Trials and Regulatory Affairs, Biomapas offers full support in all areas of Pharmacovigilance: from QPPV services, Local Safety Officer networks and Medical/Clinical Safety support, to full scope PV outsourcing. After 15 years of Pharmacovigilance in large international pharma companies, Martijn is well aware of all the challenges pharma industry could experience daily while trying to keep their PV systems smooth and compliant. He is therefore happy to share his broad pharmacovigilance knowledge and fully determined to help other companies with their PV needs.
Olga Asimaki
Info Scientific Board

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.
Ranjana Khanna
Info Speaker

Ranjana Khanna

Head of Pharmacovigilance Quality Assurance at Vifor Pharma
Ranjana Khanna is the Head of Pharmacovigilance Quality Assurance at Vifor Pharma, Switzerland and has over 18 years of working experience in the pharmaceutical industry. In 2001, she relocated to Switzerland from India and started her career in Drug Safety. She has experience in PV Operations and Quality Assurance (Delivering Training, Risk-Based Audit planning and conducting audits, vendor management, leading Inspections, Procedure Document writing etc.) including experience with company mergers and acquisitions and adapting PV systems. She has a thorough understanding of EU and FDA PV regulatory requirements relevant to a medicinal product and to work cultures worldwide having conducted over a 100 different audits in United States, Latin America, Middle-East, South Asia and Europe. She has participated in PV Inspections from over 10 different Health Authorities and is well versed with Inspector expectations.
Claudia Lehmann
Info Speaker

Claudia Lehmann

Vice President of Global Patient Safety & Pharmacovigilance Operations & Systems at Boehringer Ingelheim
Claudia Lehmann serves as Vice President of Global Patient Safety & Pharmacovigilance Operations & Systems for Boehringer Ingelheim. In her current role she has oversight for PV operations including PV system implementation and governance, case management, GPV writing, PV agreements with license partners, internal and external compliance and GPV vendor oversight and governance including oversight and a digital innovation lead. Claudia has designed many core processes in her area of accountability and with colleagues in teams across other functions in medicine, has implemented multiple systems and with them new technologies within BI medicine, such as remote data capture and most recently an end-to-end automation system for PV. She has also conducted interface training across the globe. In addition, she has always ensured a large internal and external network, being involved in external expert organizations such as the ICH MedDRA Management Committee, the Eudravigilance Expert Working Group headed by EMA, and in prior years the CDISC consortium. Claudia has been trained in medical information management at an affiliation of the University of Ulm, Germany.
Richard Wolf
Info Speaker

Richard Wolf

Executive Director, Pv Operations Head in the Global Clinical Safety and Pharmacovigilance group at CSL Behring
Richard Wolf is the Executive Director, Pv Operations Head in the Global Clinical Safety and Pharmacovigilance group at CSL Behring. He directs Case Management, Medical Evaluation, Manufacturing Site Pharmacovigilance Representatives, Combination Products Pv Center of Excellence, and Pv Business Process and Technology groups. Richard has been with CSL for the past 6 years, having spent the prior 12 years working across many areas in Global Medical Safety at Johnson and Johnson. He earned a BA from the University of Richmond and an MBA from Rutgers Graduate School of Management. Richard was also an Accenture manager and an Airborne Ranger qualified Infantry officer in his life prior to joining the pharma industry.
Mina George Awad
Info Speaker

Mina George Awad

Pharmacovigilance Manager and QPPV, Middle East at Kyowa Kirin International
Education Pharmacist, Bachelor of Pharmacy – Ain Shams University- Cairo – Egypt (2007) Post graduate studies in epidemiology, Pharmacovigilance, Biostatistics, Drug Adverse reactions and Pharmacotherapy, Cairo University (2018) Work Experience: Working for Kyowa Kirin International as Pharmacovigilance Manager, Middle East & LSO UAE, Oman, Kuwait and Qatar (June 2020 – current) worked for Vifor Pharma-International as Regional QPPV, MENA / LSO UAE and Quality Manager GCC (August 2018 to June 2020) Worked for Minapharm Pharmaceuticals-Egypt and Rhein-Minapharm as QPPV/ Pharmacovigilance Manager (May 2016 to July 2018) Worked for Hochster Pharmaceutical Industries-Egypt as QPPV (Dec. 2014 to April 2016) Worked for Ministry of Health- Egypt as Quality GMP, GDP,GVP,GLP (GxP) Auditor and Inspector (Nov. 2008 to Nov. 2014) , audited and inspected around 70 Pharmaceutical Companies in the region in addition to auditing the only oncology Pharmaceutical factory in the Arab region. Scientific training and experience PV Speaker and Trainer in different international conferences Has various trainings in the fields of Pharmacovigilance in addition to Pharmaceutical Quality and Auditing, as well as on job continuous training, below are the major trainings: Pharmacovigilance Training GCC (2019, 2020 & 2021)
Lidia Maksyutkina
Info Speaker

Lidia Maksyutkina

Regional Pharmacovigilance Manager, Russia and CIS at Biomapas
Lidia Maksyutkina is a Regional Pharmacovigilance Manager, Russia and CIS at Biomapas. Prior to working in pharmacovigilance, Lidia Maksyutkina has graduated Chuvash State University, faculty of medicine, qualified as a Medical Doctor. She worked in Russian Academy of Medical Science, Research Center of Neurology as a neurologist for 7 years. Lidia holds a PhD degree in medicine with a specialty in neurology. Lidia began working in Pharmacovigilance 8 years ago. She started as a PV specialist and then led the PV team in Russia ana CIS countries. She is experienced in PV system management, local PSMF maintenance, patient support, real world evidence programmes and other diverse projects.
Kristina Keeler
Info Speaker

Kristina Keeler

Senior Director of Global Safety Operations at Drug Safety Navigator (DSN)
Kristina Keeler is currently the Senior Director of Global Safety Operations at Drug Safety Navigator, based in Research Triangle Park (RTP), North Carolina.  She has more than 13 years of experience in the healthcare and pharmaceutical industry. Prior to joining DSN four years ago, Kristina held vital roles at (Ashfield, Quintiles, WRB), where she developed deep expertise in Post-Marketing, managing Medical Information programs, building Medical Information and PV departments, Post-Marketing pharmacovigilance requirements and management of vendors, budgets and PV programs.
Willemijn van der Spuij
Info Speaker

Willemijn van der Spuij

Executive Director Europe, Patient Safety at Bristol Myers Squibb
Willemijn has worked in the pharma industry for >20 years, both in Clinical Research and Safety functions. She joined BMS in 2003 in the World Wide Patient Safety organisation and is currently responsible for Patient Safety in the European Region. She has extensive experience with the development and management of the PSMF. Willemijn is the chair of EFPIA IPVG.
Laimonas Sutkus
Info Speaker

Laimonas Sutkus

Chief Technology Officer at Biomapas
Laimonas Sutkus is an IT infrastructure specialist with over 7 years of experience in software development, cloud architecture, and IT team coordination. Laimonas has mostly worked on cloud-based and artificial-intelligence-based projects with FinTech companies and startups. His career has begun as a Software Developer in Bentley but quickly rose to a Lead Developer to a Team Lead to a Chief Technology Officer in iDenfy. In early 2020 Laimonas has joined Biomapas as a Chief Technology Officer to lead a growing IT department and implement cutting-edge automation solutions. Biomapas is a functional and full outsourcing solution provider to the global life science industry.
Bert van Leeuwen
Info Speaker

Bert van Leeuwen

Deputy Qualified Person for Pharmacovigilance (QPPV) at Astellas Pharma Europe
Biography available soon
Alex Bica
Info Speaker

Alex Bica

Director, Clinical Safety Physician, Department Global Clinical Safety and Pharmacovigilance at CSL Behring
Mihai Alexandru Bica is a Director, Clinical Safety Physician at CSL Behring in Marburg, Germany, Fellow of the Royal Society of Public Health in London, United Kingdom and Fellow of the Academy of Science in Siena, Italy. He obtained his medical degree at the University of Medicine Iasi, Romania in 2006 and specialised in infectious diseases epidemiology in 2012; He completed his MPH studying Health Management, Bioinformatics and Biostatistics and has an executive Master degree in Vaccinology and Pharmaceutical Clinical Development from the University of Medicine Siena, Italy where he graduated “cum laude” in 2016. He is currently overseeing the active monitoring and continued assessment of safety profiles of a wide range of therapeutics and conducts multiple clinical research activities in therapeutic areas such as Immunology, Infectious Diseases, Respiratory and Transplant. Previously he lead clinical and pharmaco-epidemiological research activities with prophylactic mRNA-based and recombinant vaccines focusing on rabies, influenza, meningitis, shigella and various oncological indications at GSK and CureVac AG. Prior to this he served as Head of the Epidemiology and Disease Control Department at the National Public Health Authority of Romania within the Ministry of Health where he coordinated several national programs for immunizations, infectious disease control and epidemic and pandemic preparedness. He has successfully interacted with international groups interested in clinical and epidemiological research as also public health issues regarding migrant health. These include the World Health Organization (WHO) or the European Centre for Disease Prevention and Control (ECDC). His publication includes several manuscripts on various topics in public health, infectious diseases, epidemiology and rare diseases
Gianluca Trifirò
Info Speaker

Gianluca Trifirò

Full Professor of Pharmacology at University of Verona
Gianluca Trifirò is MD, with post-graduate degree in Clinical Pharmacology (University of Messina, Italy), Master of Science in Clinical Epidemiology (NIHES, NL) and PhD in Clinical Pharmacology (University of Messina) and Pharmacoepidemiology (Erasmus Medical Center, Rotterdam, NL). He currently works as Full Professor of Pharmacology at the University of Verona and with honorary position at the Department of Medical informatics of the Erasmus Medical Center of Rotterdam. He is member of the Scientific Secretariat of postmarketing surveillanve Office of the Italian Drug Agency and clinical pharmacologist of Phase I Clinical Trial Unit of Bambino Gesù Pediatric Hospital of Rome (Italy). He is scientific coordinator of an Academic Master program on “Use of Real world data for evaluations in Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics” at University of Verona and he is the scientific coordinator of the Italian Society of Pharmacology working group on pharmacovigilance, pharmacoepidemiology, pharmacoeconomics and & Real World Evidence. He has been active in the field of pharmacovigilance and pharmacoepidemiology since around 20 years. He is member of the steering group of the International Society of Pharmacovigilance and of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) of European Medicine Agency and member of advisory board of International Society of Pharmacovigilance. He is member of Editorial Boards of Drug Safety, Pharmacoepidemiology and Drug Safety, Biodrugs, and Clinical Drug Investigation. Authors of more than 200 publications on international scientific peer-reviewed journal.
Marie-Charbel El Chalouhi
Info Speaker

Marie-Charbel El Chalouhi

International Pharmacovigilance Operational Excellence at AbbVie
Biography available soon
J Vijay Venkatraman
Info Speaker

J Vijay Venkatraman

Managing Director & CEO at Oviya MedSafe
Dr J Vijay Venkatraman is a Diabetologist, Drug Safety Physician and Entrepreneur, with 16 years of experience. He holds a MBA degree in Services Management. He is the first Indian to have been conferred the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. Dr Vijay founded Oviya MedSafe, a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in Coimbatore, India and London, UK, which has been fulfilling the compliance needs of the global pharmaceutical industry since 2012. Dr Vijay holds the honorary position ‘Regional Editor, India’ of Global Forum, the official magazine of the Drug Information Association (DIA). He has been the Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR), since the inception of the council in 2015. Dr Vijay is an invited speaker and chairperson in national and international conferences. He has numerous publications to his credit. He is a member of several professional associations and is actively involved in promoting pharmacovigilance awareness among all stakeholders of the discipline. Dr Vijay is a recipient of many awards including the ‘Leadership Excellence Award’ and the ‘State Appreciation Award for Co-ordinating Academic Activities’ by the Indian Medical Association.
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 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 maintains the Vifor Pharma Pharmacovigilance System Master File (PSMF) and provides guidance to Regional and local QPPVs on the creation of PV Sub System Files (PSSF).
Contacts

Francesca Archetti
Operations and Training Manager
francesca.archetti@lsacademy.com
+39 379.1493191

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


Registration Fee

Full attendance | 5 appointments

€ 480,00* Super Early Bird fee until April 17th, 2021
€ 560,00* Early Bird fee until May 15th, 2021
€ 650,00* Ordinary fee
€ 320,00* Freelance, Academy, Public Administration

* for Italian companies: +22% VAT

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

Past Conferences
2020
A Global Pharmacovigilance Network: Opportunities and Challenges
2019
Pharmacovigilance within and without borders
Book Now
Super Early Bird
Available until 17/04/2021
480,00
Early Bird
Available until 15/05/2021
560,00
Ordinary
Available until 13/06/2021
650,00
Freelance – Academy – Public Administration
Available until 13/06/2021
320,00
Clear

Become Sponsor Printable Version
Media Partner

<p>Virtual conference on Zoom platform.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

Virtual conference on Zoom platform.
LS Academy will provide the link to join the conference some days before.

<p>Virtual conference on Zoom platform.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>