About

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).
Programme

More details available soon

Speakers
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.
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.
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.
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

€ 670,00* Early Bird fee until September 21st, 2021
€ 790,00* Ordinary fee
€ 430,00* Freelance, Academy, Public Administration

* for Italian companies: +22% VAT

Fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, welcome coffee, networking lunch, coffee break, organisational office assistance, certificate of attendance.


Informazioni utili

Park Inn by Radisson Copenhagen Airport
Engvej 171, 2300 Copenhagen S, Denmark

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
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
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<p><strong>Park Inn by Radisson Copenhagen Airport</strong><br />
Engvej 171, 2300 Copenhagen S, Denmark</p>
<p>&nbsp;</p>

Park Inn by Radisson Copenhagen Airport
Engvej 171, 2300 Copenhagen S, Denmark

 

<p><strong>Park Inn by Radisson Copenhagen Airport</strong><br />
Engvej 171, 2300 Copenhagen S, Denmark</p>
<p>&nbsp;</p>
<p><strong>Park Inn by Radisson Copenhagen Airport</strong><br />
Engvej 171, 2300 Copenhagen S, Denmark</p>
<p>&nbsp;</p>

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