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?
Programme
All times indicated are Central Europe Summer Time
Speakers
Doris Stenver
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
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
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.
Alex Aarsø
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
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
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
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.
Line Michan
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
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
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.
Contacts
Ilaria Butta
Events & Training Executive
+39.379.1492960
ilaria.butta@lsacademy.com
Registration Fee
€ 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.
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