Date

28 October 2020

Location

Virtual

Language

English

Nordic Pharmacovigilance Day Virtual

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Nordic Pharmacovigilance Day Virtual

Covid-19 is creating the biggest international emergency nowadays.
Nordic Pharmacovigilance Day doesn’t stop, the conference will move to a virtual format: NORDIC PHARMACOVIGILANCE DAY VIRTUAL. 
Join the virtual conference from home or from the office and keep you updated about the most interesting pharmacovigilance topics in Nordic Countries!


New perspectives and future needs of Pharmacovigilance in the Nordic Countries: embracing the opportunities ahead

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). 

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

Download the Agenda
Certificate of attendance

28 October 2020

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?

Line Michan Line Michan – Medicines Inspector at Danish Medicines Agency

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.

Inge  Zomerdijk Inge Zomerdijk – Senior Pharmacovigilance Assessor at Medicines Evaluation Board (MEB)

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.

Liliana  Hansen Liliana Hansen – Senior Director, Head of Pharmacovigilance at Zealand Pharma

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.

Linda Matti Linda Matti – Senior Device Vigilance & Process Manager, Global Pharmacovigilance, PV Surveillance at Ferring

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, Betina 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. 

Betina  Østergaard Eriksen Betina Østergaard Eriksen – Vice President, Safety Surveillance at Novo Nordisk

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. 

Kåre Kemp Kåre Kemp – Head of EU Pharmacovigilance at Danish Medicines Agency

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?

Martin Holm-Petersen Martin Holm-Petersen – CEO at Insife

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).

Alex Aarsø Alex Aarsø – Sr. Project Manager at Novo Nordisk A/S

Scientific Board

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

Speakers

Alex Aarsø
Alex Aarsø Sr. Project Manager at Novo Nordisk A/S
Liliana  Hansen
Liliana Hansen Senior Director, Head of Pharmacovigilance at Zealand Pharma
Martin Holm-Petersen
Martin Holm-Petersen CEO at Insife
Kåre Kemp
Kåre Kemp Head of EU Pharmacovigilance at Danish Medicines Agency
Linda Matti
Linda Matti Senior Device Vigilance & Process Manager, Global Pharmacovigilance, PV Surveillance at Ferring
Line Michan
Line Michan Medicines Inspector at Danish Medicines Agency
Betina  Østergaard Eriksen
Betina Østergaard Eriksen Vice President, Safety Surveillance at Novo Nordisk
Inge  Zomerdijk
Inge Zomerdijk Senior Pharmacovigilance Assessor at Medicines Evaluation Board (MEB)

Scientific Board

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

Conference Venue

Nordic Pharmacovigilance Day Virtual

Virtual conference with presentations, interactive sessions, slots for Q&A and discussion among delegates.

Useful information

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

All times indicated on the Agenda are Central Europe Summer Time.

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

Useful numbers

Ilaria Butta
Ilaria Butta Events & Training Executive
Annalisa De Biasi
Annalisa De Biasi Project & Scientific Manager
Enrico Pedroni
Enrico Pedroni Managing Director

Past Events

Conference Price

680.00 €

Early Bird

Monday, October 5, 2020

560.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

For information:

Contacts:

Ilaria Butta
Ilaria Butta Events & Training Executive
Annalisa De Biasi
Annalisa De Biasi Project & Scientific Manager
Enrico Pedroni
Enrico Pedroni Managing Director
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Technical and scientific training in the
pharmaceutical field
Via Roma 20 – 24022 – Alzano Lombardo (BG)
Tel: +39 035 515684

Participants' Feedbacks

Input from different companies / perspectives, variety of topics

Very relevant topics. Great speakers

Good mixed programme, valuable to exchange experience and views

Very good relevant topics, well presented topics from the speakers

General very experienced speakers, Different PV topics

The lenght of thr breaks was good, we had time for networking

Could be nice to have a follow up next year. This is also relevant to follow up on the topic in general and status in relation to regulators perspective. High quality in general for all the sessions

Very good topics this year

Very current and relevant topics, competent key speakers

Very competent board! It was actually nice that we were not more than approx. 50 people, the dialog and networking in this setting was really good.

Very interesting to hear about the ****** strategy! Super relevant to hear about AI and literature screening (I would love to have this feature!)

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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.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

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The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

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Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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