About

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.

Programme

More info available soon

08.30
09.00
Registration
09.00
09.10
Welcome
09.10
09.30
PV Inspections - Regulatory perspective
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
10.10
10.40
Coffee break
10.40
11.10
Signal Detection - Regulatory Perspective
Karin Erneholm - Pharmacovigilance Officer at Danish Medicines Agency
11.10
11.40
Signal Detection - Company Perspective
Jannik Høvring Nielsen - Safety Surveillance Specialist for Signal Detection at Novo Nordisk A/S
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
13.40
AI and machine learning
Martin Holm-Petersen - CEO at Insife
Jen Markey - Chief Sales & Marketing Officer at Insife

Abstract will be available soon

13.40
14.10
Privacy Aspects in PV Processes
Gro Laier - Pharmacovigilance Expert

Abstract will be available soon

14.10
14.40
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

Abstract will be available soon

14.40
15.10
Coffee break
15.10
16.10
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.

16.10
16.20
Conclusions
Speakers
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
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
Bio will be available soon
Gro Laier
Info Speaker

Gro Laier

Pharmacovigilance Expert
Bio will be available soon
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.
Contacts

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

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


Registration Fee

€ 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.


Useful Information

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)

Past Conferences
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
Become Sponsor Printable Version
<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>

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