Introduzione

In Pharmacovigilance, we are entering extraordinary times. Evolutions in technology, regulations, and processes bring along unprecedented challenges as well as new opportunities for all involved parties including patients and their caregiver, the investigators, the health care professionals, the regulators, the sponsors, the vendors and CROs.

While the shorter-term benefits of digitalization are gradually becoming tangible, there are also longer-term aspirations to transform the entire operating model in the field of pharmacovigilance.

For the 7th Nordic Pharmacovigilance Day conference 2020 we are posed with the following questions:

  • What are the challenges for our QPPVs – locally and globally?
  • What is the impact of the new EU-medical device regulation on pharmacovigilance of devices and combination products?
  • What are the Risk Minimization Measures outcomes and how to measure the effectiveness?
  • RWE and Big Data - Signal management, how to manage in the best way?
  • Inspection Readiness – What are the emerging trends in the field of pharmacovigilance and how to prepare your organization?
  • New PV tools, machine learning and AI (data protection and Signal detection – requirements, challenges and compliance). Are we ready to monitor the patient safety in the new digital era?
  • Outsourcing in PV, how to ensure oversight and how to be compliant?

The future is here, and we need to shape it to provide enhanced solutions for a better health and quality of life for patients. This meeting is a key opportunity to network and learn from knowledgeable speakers and experts in this area.

Scientific Board

Wasim Anwar - Director, Safety Surveillance - Biopharm, Diabetes Insulin & Devices at Novo Nordisk A/S
Caroline Susanne Sandström - Senior Specialist GCP/GLP/GVP Compliance Global QA R&D at Ferring Pharmaceuticals A/S
Doris Stenver - Independent Pharmacovigilance Adviser, Founder of Unique Advice

Who should attend?

This conference is designed to benefit functional/technical professionals working in the pharmaceutical and healthcare 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 Manufacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, PhD students).
Programma

All times indicated are Central Europe Summer Time

10:00
10:20
Welcome
10:20
10:45
Ensuring Compliance in a Changing World - Inspection Perspectives
Line Michan - Medicines Inspector at Danish Medicines Agency

The world of medicines and usage of medicines is ever changing and increased globalization is providing more opportunities for companies and authorities to communicate and organize their activities worldwide. Likewise the flow and amount of data including drug safety information has vastly increased. Recent years has also provided important technical developments and possibilities to support pharmacovigilance processes with automation and IT-solutions.

The presentation provides the perspective from a pharmacovigilance inspector, on how to balance the new settings and possibilities while ensuring compliance and adequate quality for reliable assessment of pharmacovigilance data and benefit-risk profiles of medicines. How do we as inspectors make best use of available data and global networks for our inspections? And what typical pitfalls and challenges do we see in companies when we conduct pharmacovigilance inspections?

10:45
11:10
Outcome of Risk Minimization Measures
Inge Zomerdijk - Senior Pharmacovigilance Assessor at Medicines Evaluation Board (MEB)

Risk minimization measures (RMM) aim to prevent or reduce the occurrence or severity of an adverse drug reaction when a medicine is used in daily practice, and RMM play an important role in strengthening the positive benefit-risk balance of a medicine. During the post-marketing period it is important to monitor the outcome of these measures in order to ensure that RMM have fulfilled their objectives i.e. the risks are sufficiently minimized, well as to provide evidence if any changes to the RMM or their implementation may be necessary.

During this session methods used for assessing the effectiveness of RMM including their outcomes will be presented. Experiences from regulatory perspective as well as results from ongoing research on outcome of evaluation and the subsequent changes in RMM during post-marketing period will also be addressed. All topics will be supported with examples and case studies allowing an interactive discussion with the audience.

11:10
11:30
Break
11:30
11:55
Outsourcing in Pharmacovigilance - Should Anyone Dare?
Liliana Hansen - Senior Director, Head of Pharmacovigilance at Zealand Pharma

The Pharmacovigilance domain consists of specialized and complex set of activities and pharmaceutical companies, irrespective of their size struggle with the resource and competency constraints in this area both during product clinical development and life cycle management.

This session will focus on a small Danish pharma company’s approach to outsourcing of PV activities including benefits and challenges encountered. One should always remember that independent of outsourcing only a certain set of assignments or tasks – partially or completely – the responsibility always resides with the sponsor. How to maintain an effective oversight will be the key take-home learning from this session.

11:55
12:20
New Medical Device Regulation in Europe – Are you Ready?
Linda Matti - Senior Device Vigilance & Process Manager, Global Pharmacovigilance, PV Surveillance at Ferring

Back in May 2017, a new Medical Devices Regulation (MDR) (2017/745) in Europe was published in the official Journal of the European Union providing the industry with a three years’ transition period to meet the MDR requirements. However, due to Covid-19 pandemic, the European Parliament adopted European Commission’s proposal to extend the transition period with one year ending the new extended transition period on 26th of May 2021.

The new MDR covers updates to Vigilance and Post-Market Surveillance requirements while introducing a new role of Person Responsible for Regulatory Compliance (PRRC) that ensures manufacturer’s compliance with Vigilance and Post-Market Surveillance requirements. The MDR also addresses economic operators role to cover their supply chain responsibilities. Additionally, the MDR introduces a new requirement to obtain Notified Body opinion for medicinal products with integral device part for their marketing authorisation in Europe.

During the session, further details on MDR’s Vigilance and Post-Market Surveillance requirements will be provided and best practice examples will be shared.

12:20
13:20
Lunch break
13:20
14:05
INTERACTIVE SESSION | Patient Safety during Pandemic Situation - Sharing Lessons Learned
Betina Østergaard Eriksen - Vice President, Safety Surveillance at Novo Nordisk

Moderator: Doris Stenver – Independent Pharmacovigilance Adviser, Founder of Unique Advice

Interactive session to share learnings from the pharma industry related to ensuring patients safety and pharmacovigilance during pandemic situation. Initially, Bettina Østergaard Eriksen from Novo Nordisk will briefly share perspective on the experiences from the recent situation.

The session will then open up for the participants to share experiences across the pharma industry and create a mutual learning environment based on dialogue amongst the participants/audience.

14:05
14:30
Using Danish Registries as Sources of Real-World Data for Signal Detection, Validation and Assessments: Examples from the Danish Medicines Agency (DKMA)
Kåre Kemp - Head of EU Pharmacovigilance at Danish Medicines Agency

Denmark has a long tradition for using registries to collect data either for individual treatment purposes or as valuable tools for epidemiological research. In addition, these registries provide a unique base for novel use of real world evidence in signal detection, validation and assessment. In the past years the major part of validated signals raised to the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency’s (EMA) from DKMA originated from other sources than traditional databases with spontaneously reported adverse drug reactions, which is in contrast to most other member states and EMA.

In this presentation examples of analyses of registry data turning into regulatory actions will be discussed. With registries becoming more frequent worldwide, they will be a major potential source for early detection of new signals. Key experiences from the examples will be outlined for future considerations.

14:30
14:50
Break
14:50
15:15
Can Artificial Intelligence change our Fundamental Approach to Safety Signal Detection and How far is it Today?
Martin Holm-Petersen - CEO at Insife

Drug Safety information from clinical trials and marketed products is predominantly processed by manual methods, with some basic means of scripted automation that basically has been available for the last 20 years. Equally, signal detection technology and methodologies, to detect or defer concerns / potential risks seen with a drug, have been fairly stagnated for many years. With the wealth of cutting edge technologies available today, including Artificial Intelligence / Machine Learning and Big Data Analytics on vast healthcare data, could we do something more profound to change how we analyze and extract knowledge?

This session will explore the potential and pitfalls of introducing these new technologies and data sources to signal detection and also reflect on recent advancements in the area. Fundamental questions are to be answered: What are the potential gains in terms of patient safety? How would this work in practice and how mature is the technology for safety signal detection? Will it provide efficiency gains / is there a positive return on investment? Or will this lead to far more work in Industry?

15:15
15:40
ccAI – an Example of Using AI/ML (Artificial Intelligence & Machine Learning) in Case Intake
Alex Aarsø - Sr. Project Manager at Novo Nordisk A/S

In this presentation the implementation of the ccAI project in Novo Nordisk Global Safety Customer Complaint Center is described. The aim of the project is to automate parts of the device complaint Triage process, by using emerging technologies.

We will describe the technologies used and the underlying theories. We will explain which technology has been chosen for implementation, its limitations and where we have combined the technology with other techniques in order to handle the business needs.

Using machine learning introduces a new set of concepts and questions that needs to be tackled:

– Designing processes that take erroneous machine decisions into account.
– What accuracy and error rates are acceptable?
– When and how often will we need to re-train the machine learning system.

These concepts and questions will be discussed as seen from a PV business perspective, and if possible then we will present the results from the AI design (project is not scheduled to be concluded by October 2020).

15:40
15:45
Conclusion
Relatori
Doris Stenver
Info Scientific Board

Doris Stenver

Independent Pharmacovigilance Adviser, Founder of Unique Advice
Graduated from Copenhagen University, the Medical Faculty, in 1986. She became specialist in internal medicine in 1995. Following 12 years employment at university hospitals in the Copenhagen area she joined the Danish Medicines Agency in 1998 and was appointed Chief Medical Officer in 2002. She was member of the Pharmacovigilance Working Party 1998 – 2012 and of the Pharmacovigilance Risk Assessment Committee from July 2012 until February 2019. Her experiences cover all aspects of pharmacovigilance, including the legal framework, scientific and strategic aspects and communication. In 2007 she achieved a master degree in public administration from Copenhagen Business School. In March 2019 she founded the independent consultancy Unique Advice, specialized in pharmacovigilance.
Caroline Susanne Sandström
Info Scientific Board

Caroline Susanne Sandström

Senior Specialist GCP/GLP/GVP Compliance Global QA R&D at Ferring Pharmaceuticals A/S
Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. Her special interest for chronic inflammation, pharmacology and immunology was reflected in the thesis which was dealing with both human and murine-based systems. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects. Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. She was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture. After almost seven years in Novo Nordisk A/S, Caroline Sandström started as Compliance Director at Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she is involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She is taking a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area. Her scientifically driven problem solving skills are today used for implementing global cross-functional compliance projects, supporting and strengthening the quality mindset in the organization.
Wasim Anwar
Info Scientific Board

Wasim Anwar

Director, Safety Surveillance - Biopharm, Diabetes Insulin & Devices at Novo Nordisk A/S
Wasim Anwar is a medical graduate from King Edward Medical University, Lahore and holds a PgD in Pharmacovigilance from University of Hertfordshire, UK. He has over 10 years of experience in the field of pharmacovigilance while working in different biopharmaceuticals companies in various capacities. Currently he is heading up the department of Safety Surveillance, Global Safety Novo Nordisk A/S and leading a team of pharmacovigilance experts responsible for safety monitoring activities including signal detection and risk management for products within Biopharm, Insulins, Devices and Digital Health portfolio.
Alex Aarsø
Info Speaker

Alex Aarsø

Sr. Project Manager at Novo Nordisk A/S
Alex has worked 4 years at Novo Nordisk as a project manager with focus on IT implementations and use of emerging technologies. Prior experience comes from 15 years in IT (mostly IBM), working in PM and management positions.
Liliana Hansen
Info Speaker

Liliana Hansen

Senior Director, Head of Pharmacovigilance at Zealand Pharma
Senior international pharma leader, visionary and passionate for creating and delivering sustainable solutions to answer patient needs. I achieve results through talent management, building and leading world-class teams in a global setting. With nearly 25 years-experience in pharma industry with Novo Nordisk, LEO Pharma, Eli Lilly, Santaris Pharma and latest Zealand Pharma in different roles, different functional and therapy areas (diabetes, bleeding disorders, intensive care, cancer and dermatology), I have built competencies in drug and device development and commercialization. My core expertise is within drug safety/pharmacovigilance, medical science and medical communication, regulatory processes (dossier/label negotiations with major regulatory authorities) and clinical quality assurance.
Martin Holm-Petersen
Info Speaker

Martin Holm-Petersen

CEO at Insife
With 10 years of experience within the pharmaceutical industry and another 10+ years in consulting, Martin is an experienced manager and strategist, with understanding across the pharma business value chain, and an expert on Pharmacovigilance. His current role is CEO of Insife, a global consulting and technology company, supporting life sciences companies. In his previous role, he headed the pvtech global industry pharmacovigilance technology network with more than half of top 100 pharma participating. From industry, Martin has seven years of experience at senior management level and has furthermore been engaged as a governance Board member for project investments at a top 10 pharmaceutical company. Key areas of expertise include: Strategy development, planning and implementation Digital transformation and big/real-world data in pharma Pharmacovigilance, Regulatory and Clinical process optimization Program and portfolio management Data integration and business intelligence Qualifications and Awards MSc Communication Studies SIMI / MMPIPrince2, P3O Practioner
Kåre Kemp
Info Speaker

Kåre Kemp

Head of EU Pharmacovigilance at Danish Medicines Agency
Kåre is heading EMA/EU related activities within pharmacovigilance at the Danish Medicines Agency and has since 2015 been focusing on safety surveillance. He has a broad background following 15 years in the pharmaceutical/biotech industry in various leadership positions, ranging from discovery to safety. Prior to the industry, he did a M.Sc. in experimental biology and a Ph.d. and post doc within immunology/medicine. He has supervised M.Sc. and Ph.d. students, participated in several research boards bridging industry and academia and has 40+ peer reviewed co-authorships in international journals.
Linda Matti
Info Speaker

Linda Matti

Senior Device Vigilance & Process Manager, Global Pharmacovigilance, PV Surveillance at Ferring
Biography available soon
Line Michan
Info Speaker

Line Michan

Medicines Inspector at Danish Medicines Agency
Line Michan is currently Medicines Inspector with main responsibility for pharmacovigilance inspections and she is part of the EU Pharmacovigilance Inspectors Working Group. Line Michan has been working with patient safety and pharmacovigilance at the Danish Medicines Agency since 2007, where she has been involved in both national safety surveillance as well as in the EU Pharmacovigilance Risk Assessment committee. Line Michan holds a Master degree and a PhD in Science from the University of Copenhagen.
Betina Østergaard Eriksen
Info Speaker

Betina Østergaard Eriksen

Vice President, Safety Surveillance at Novo Nordisk
Betina Østergaard Eriksen is currently Vice President, Safety Surveillance at Novo Nordisk, where she is responsible for signal management, risk management and aggregate reporting across the product portfolio. She is a registered physician from the University of Copenhagen. Since joining the pharmaceutical industry in 2001, she has been working in different European and global leadership roles across R&D, where she has broad pharmacovigilance experience from almost 15 years in drug safety in different companies.
Inge Zomerdijk
Info Speaker

Inge Zomerdijk

Senior Pharmacovigilance Assessor at Medicines Evaluation Board (MEB)
Inge Zomerdijk is currently working at the pharmacovigilance department of the Medicines Evaluation Board (MEB) in the Netherlands since 2010. She is a senior pharmacovigilance assessor and as a regulator she has experiences in assessing Risk Management Plans, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center in Rotterdam, the Netherlands. Her research was specifically focused on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry. She is still involved in research that the MEB in collaboration with universities is conducting in the field of outcome of risk minimisation measures.
Contatti

Ilaria Butta
Events & Training Executive
+39.379.1492960
ilaria.butta@lsacademy.com

Quote di iscrizione

€ 560,00* Early Bird fee until October 5th, 2020
€ 680,00* Ordinary fee
€ 390,00* 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.

Edizioni Passate
2019
“Hot topics" - Increasing Awareness of Significant and Essential Needs in Pharmacovigilance
2018
Pharmacovigilance Challenges: Hot Topics in 2018
2017
Pharmacovigilance Challenges: Hot Topics in 2017
2016
Pharmacovigilance Challenges: Hot Topics in 2016
2015
Hot Topics in Pharmacovigilance
Acquista

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<p style="text-align: center;">Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

Virtual conference with presentations, slots for Q&A and discussion among delegates.
LS Academy will provide the link to join the conference some days before.

<p style="text-align: center;">Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>