Introduzione

Current Challenges and Emerging Trends in Pharmacovigilance: a Focus on the Nordic Countries

The Nordic Pharmacovigilance Day conference has become a yearly key meeting for all the professionals working in pharmacovigilance and related areas in the Nordic countries.
The 9th edition will be held in Copenhagen on 13 October 2022 and the agenda will cover the updated most important topics within the safety of medicinal product and medical devices.
With the collaboration of experienced and knowledgeable speaker, the conference will offer interactive sessions, high level presentations and useful discussions about the practical aspects of the daily work in PV.

Among others, we will cover the following topics:
• PV Inspections focus and trends: experience from the industry and perspectives from regulator’s
• Practical aspects of PV assessment of vendors and Safety Data Exchange agreements
• Data privacy in handling of safety data: challenges and approaches
• Signal management considerations in evolving landscape
• New trends in PV: Artificial Intelligence & Machine Learning

 

Scientific Board

  • Wasim Anwar - Vice President & Deputy QPPV - Head of QPPV Office, Global Safety at Novo Nordisk A/S
  • Caroline Susanne Sandström - Head of Global Clinical Quality at Ferring Pharmaceuticals A/S
  • Mette Stie Kallesøe - Deputy QPPV, Global Safety Standards & Compliance Global Safety at LEO Pharma

 

Who should attend?
The conference program is designed for healthcare professionals or pharmacists working in the pharmacovigilance 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, vendors and CROs working with patient safety data.

Programma
08.30
09.00
Registration
09.00
09.10
Welcome
09.10
09.30
PV Inspections - Experience from a regulatory perspective
Maria Laustsen Murholm - Compliance Specialist for Digital Health at Novo Nordisk

Even though it has been many years since the introduction of the pharmacovigilance legislation, pharmacovigilance inspections remain an important topic. Being inspection ready as a Marketing Authorisation Holder (MAH) is something we have all heard before, but what does it mean from the inspectorates side?

In this session you will gain knowledge about considerations and preparations for pharmacovigilance inspections from regulators perspective. The talk will provide an overview of planning of inspection programme and individual inspection plans with a focus on:

  • Collaboration within the EMA
  • Collaboration with assessors
  • Publicly available information
  • Information pertaining to the individual MAHs present in Art 57.

Understanding  potential areas in scope for an announced inspection will support effective management of resources during the preparation of inspections

09.30
09.50
PV Inspections -Company perspective
Mette Stie Kallesøe - Deputy QPPV, Global Safety Standards & Compliance Global Safety at LEO Pharma

Abstract will be available soon

09.50
10.10
Panel discussion
Mette Stie Kallesøe - Deputy QPPV, Global Safety Standards & Compliance Global Safety at LEO Pharma
Maria Laustsen Murholm - Compliance Specialist for Digital Health at Novo Nordisk
10.10
10.40
Coffee break
10.40
11.10
Signal Detection in the pandemic
Karin Erneholm - Pharmacovigilance Officer at Danish Medicines Agency

Since the beginning of the COVID-19 pandemic, there has been an unforeseen exposure of medicinal products in the combat against the coronavirus, both therapeutics as well as vaccines. In the end of 2020, the first COVID-19 vaccine reached conditional marketing status in the EU/EEA. An exceptional exposure within a short time frame, in combination with stimulated reporting of suspected side effects, led to an enormous load of individual case safety reports, and consequently, the pharmacovigilance system faced challenges accordingly. With the large amount of data also came the possibility and opportunity to complement the safety surveillance and signal detection activities with register data.

This presentation will give examples of when the signal detection activities have successfully been complemented by register data, in the COVID-19 pandemic setting.

11.10
11.40
Signal Detection from industry perspective. Past, present and the future
Jannik Høvring Nielsen - Safety Surveillance Specialist for Signal Detection at Novo Nordisk A/S

This talk will provide an overview of implementation of the Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management from industry perspective and will provide an outline of the signal management process in a big pharma.

It will also touch upon current state and the challenges for heading into the future for the signal detection, where new local requirements are emerging and new data sources are offering new possibilities and complexities for the signal detection and reporting.

 

11.40
12.00
Q&A on Signal Detection Session
Karin Erneholm - Pharmacovigilance Officer at Danish Medicines Agency
Jannik Høvring Nielsen - Safety Surveillance Specialist for Signal Detection at Novo Nordisk A/S
12.00
13.00
Lunch
13.00
14.00
Workshop in groups

During this interactive session, participants will be divided in groups and will have the possibility to discuss about specific topics.

The list of topics will be announced soon.

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

14.00
14.40
Solving the PV technology puzzle in the digital era
Martin Holm-Petersen - CEO at Insife
Jen Markey - Chief Sales & Marketing Officer at Insife

Part 1  (Jen Markey)

If your company’s PV landscape is similar to most, you do not have just one safety (vigilance) solution, you have many. Some for data & documents, some for communication, reporting, reference libraries, etc. Many different technology solutions that overlap, interconnect and in some cases duplicate effort … and all of these solutions must work seamlessly together and be validated. It’s a complex environment that is increasingly challenging for most companies to manage. This presentation will discuss how to streamline and simplify while increasing transparency and compliance.

Part 2  (Martin Holm-Petersen)

The well-known safety databases were architected decades ago to fix certain problems that are not necessarily central to the PV organization anymore. Pushing for re-thinking, this presentation will consider the following questions:​

  • How can we work better with affiliates and partners, without complex and obstructive boundaries?​
  • How can we make good use of AI and machine learning, without having to spend an excessive amount of time and money?​
  • How do we handle the massive amounts of big data that are becoming available in our every-day processing? ​
  • How do we make life simpler with cloud / SaaS technology, while maintaining GxP and security?​
14.40
15.10
Coffee break
15.10
15.40
Data Privacy in Pharmacovigilance
Gro Laier - PV Expert

The aim of this presentation is to give some advice for the implementation of GDPR with focus on data minimisation in the handling of individual cases of suspected adverse reactions brought to the attention of the Marketing Authorisation Holder from spontaneous sources. Relevant quotes from the Pharmacovigilance legislation as well as from GDPR will be presented along with recommendations on data flow for individual cases and follow-up, Data Privacy notifications for reporters and patients and record retention requirements.

15.40
16.10
PV Agreements in an ever evolving regulatory landscape
Anna-Shari Melin - Senior Managing Associate (Food, Drug and Medical Device Regulatory) at Sidley Austin (CE) LLP

This presentation will focus on the complexities surrounding the inclusion of PV provisions into agreements with partners who perform tasks which are relevant to the PV system. It will (i) address how detailed such PV provisions should be depending on the specific relationship with the partner, (ii) comment on pitfalls to watch out for during negotiations of PV language / PVAs, (iii) highlight observations from PV inspections and (iv) provide food for thought with respect to PV-relevant changes in EU law. The presentation will also give guidance for negotiations on PV clauses, and why and how to insist on robust PV language which protects the company.

16.10
16.20
Conclusions
Relatori
Caroline Susanne Sandström
Info Scientific Board

Caroline Susanne Sandström

Head of Global Clinical Quality 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 Specialist at Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she has been involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area. From beginning of May 2022 she moved into the position of being Head of the Global Clinical Quality Department. Her scientifically driven problem solving skills are used for implementing global cross-functional initiatives, supporting and strengthening the harmonization and quality mindset in the organization.
Wasim Anwar
Info Scientific Board

Wasim Anwar

Vice President & Deputy QPPV - Head of QPPV Office, Global Safety at Novo Nordisk A/S
Wasim Anwar is a medical graduate from King Edward Medical University, Pakistan and holds a PgD in Pharmacovigilance from University of Hertfordshire, UK. He has over 10 years of experience in the field of pharmacovigilance (PV) while working in different biopharmaceuticals companies in various capacities both as a PV professional as well as a leader. Currently he is working at Global Safety, Novo Nordisk A/S as Deputy QPPV and heading up the team of pharmacovigilance experts responsible for supporting and maintaining global oversight and compliance to pharmacovigilance regulations and processes.
Mette Stie Kallesøe
Info Scientific Board

Mette Stie Kallesøe

Deputy QPPV, Global Safety Standards & Compliance Global Safety at LEO Pharma
Mette has an MSc in Pharmacy from the then Royal Danish School of Pharmacy and a MSc in Pharmacovigilance from the University of Hertfordshire, UK. She has profound knowledge of global pharmacovigilance legislation, compliance, impact assessments, pharmacovigilance processes and systems stemming from more than 20 years pharmacovigilance experience from Ferring, Novo Nordisk and LEO Pharma. In her previous positions she has been responsible for case processing for post-marketing and clinical trials, coordinating and providing PV input audits and inspections PV, GCP and GMP areas, for PV intelligence and impact assessments of new legislation, QPPV review and approval of PSURs, ACOs and RMPs, responses to regulatory requests and compliance with GDPR across safety processes. In her current role she is one of two deputy QPPVs at LEO Pharma
Karin Erneholm
Info Speaker

Karin Erneholm

Pharmacovigilance Officer at Danish Medicines Agency
Karin Erneholm is pharmacovigilance officer at the Danish Medicines Agency where she is working primarily with EU procedures; signal management, signal detection and PSUR assessments. Karin holds a master degree in Veterinary medicine, a PhD in in vivo pharmacology/immunopathology, and worked at a pre-clinical contract research organization prior to joining the Danish Medicines Agency in 2019.
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
Jannik Høvring Nielsen
Info Speaker

Jannik Høvring Nielsen

Safety Surveillance Specialist for Signal Detection at Novo Nordisk A/S
Jannik Høvring Nielsen is working in Global Safety as a Safety Surveillance Specialist at the Novo Nordisk headquarters in Denmark. He has 14 years of experience within pharmacovigilance, 9 of these with Novo Nordisk. During his time in Safety Surveillance Jannik has gained extensive experience in surveillance of marketed products as well as clinical trials, including submission of a new product application to authorities worldwide, including FDA and EMA. Jannik is currently working with the signal management process at Novo Nordisk, implementation of methodology and strategy for Digital Health data as well as a project to implement new IT tools for signal management and aggregated reports. Prior to joining Novo Nordisk, Jannik worked 5 years for a large pharmaceutical company where he worked with all areas of pharmacovigilance. Jannik has a master’s degree in pharmacy from University of Copenhagen, Faculty of Pharmaceutical Sciences from 2007, and a post-graduate diploma degree in pharmacovigilance from University of Hertfordshire in UK from 2012.
Gro Laier
Info Speaker

Gro Laier

PV Expert
Gro Laier, MD graduated from University of Copenhagen in 1987 and have been working within Pharmacovigilance for more than 25 years. She has been working with every aspect of drug safety and pharmacovigilance; but has been focusing on regulatory surveillance, case handling processes and latest data privacy in Pharmacovigilance.
Maria Laustsen Murholm
Info Speaker

Maria Laustsen Murholm

Compliance Specialist for Digital Health at Novo Nordisk
Education: BSc and MSc in Molecular Biology, University of Southern Denmark; PhD in Basic Metabolic Research, Faculty of Health and Medical Sciences, Copenhagen University; Pg Diploma in Pharmacovigilance, University of Hertfordshire. Positions: PV Specialist at Leo Pharma, Senior Safety Surveillance Advisor at Novo Nordisk, GVP and inspector of medical devices in clinical investigation at Danish Medicines Agency Current position: Compliance Specialist for Digital Health at Novo Nordisk
Jen Markey
Info Speaker

Jen Markey

Chief Sales & Marketing Officer at Insife
Jen has 25+ years of industry, consulting, and software development experience in the Pharmaceutical & Financial industries. The last 23 years of her career have been focused on Drug Safety & Pharmacovigilance and she has worked with many of the top pharmaceutical companies in the world, including Johnson & Johnson and Pfizer. She also spent many years working as a management consultant where she focused on helping a wide range of clients establish, improve, and streamline their safety processes and technology solutions. In her current role as Chief Sales & Marketing Officer at Insife she will strive to continue to bring the best technology and consulting services to the life sciences industry. Key areas of expertise include: Drug Safety & Pharmacovigilance technology solutions Business process improvement and redesign Pharmacovigilance regulation Qualifications and Awards BSc in Computer Science from Dublin City University
Anna-Shari Melin
Info Speaker

Anna-Shari Melin

Senior Managing Associate (Food, Drug and Medical Device Regulatory) at Sidley Austin (CE) LLP
ANNA-SHARI MELIN is a life sciences lawyer and German Rechtsanwältin. Her practice combines EU and German regulatory, compliance, and private equity/M&A expertise. Her clients are pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer good companies. Anna’s regulatory advice spans the product life cycle including analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs and market access, pharmacovigilance, medicinal product shortages, recalls, the new medical devices regulations, pharmaceutical/device advertising, and related compliance. Anna co-leads Sidley’s benchmarking group for in-house pharmacovigilance lawyers (pvlegal) and regularly speaks on timely pharmacovigilance topics.
Contatti

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

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


Quote di iscrizione

€ 680,00*      Early Bird fee until 15 September 2022
€ 790,00*      Ordinary fee
€ 440,00*      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, 2 coffee breaks, organisational office assistance, certificate of attendance.


Informazioni utili

The conference will take place at:

Park Inn by Radisson Copenhagen Airport
Engvej 171 – 2300 Copenhagen

Park Inn by Radisson Copenhagen Airport is situated near both the Copenhagen Airport and the city centre. If you arrive by car, this hotel’s location in Copenhagen, Denmark provides free parking. The nearby metro and train stations are convenient for cyclists and guests without cars.

Transport options
Metro station Femøren (two stops to airport and six to city centre) – beside hotel
Copenhagen International Airport – 3 km (5 min by metro)
Copenhagen Central Station – 7 km (10 – 15 min by car)

 

COVID-19
LS Academy is aware of the evolving impact of COVID-19 and is committed to offering safe and secure face-to-face courses and conferences. From physical distancing, protect, detect, cleaning and hygiene.  LS Academy ensures that all our events are conducted in accordance with official government guidelines and regulations, understanding that these measures may vary and change as the situation evolves.

 

Edizioni Passate
2021
Sharing Current Best Practices and Strategic Approaches within Pharmacovigilance Regulated Activities
2020
New perspectives and future needs of Pharmacovigilance in the Nordic Countries: embracing the opportunities ahead
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
2014
Nordic Pharmacovigilance Day 2014
Acquista
Nordic Pharmacovigilance Day
Acquistabile fino al 15/09/2022
680,00
Nordic Pharmacovigilance Day
Acquistabile fino al 12/10/2022
790,00
Nordic Pharmacovigilance Day
Acquistabile fino al 12/10/2022
440,00

Diventa Sponsor Versione Stampabile
<p style="text-align: center;"><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171<br />
2300 &#8211; Copenhagen</p>

Park Inn by Radisson Copenhagen Airport
Engvej 171
2300 – Copenhagen

<p style="text-align: center;"><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171<br />
2300 &#8211; Copenhagen</p>
<p style="text-align: center;"><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171<br />
2300 &#8211; Copenhagen</p>
<p style="text-align: center;"><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171<br />
2300 &#8211; Copenhagen</p>