Introduzione

Sharing Current Best Practices and Strategic Approaches within Pharmacovigilance Regulated Activities

The Nordic Pharmacovigilance Day has become a very popular forum for a broad range of professionals engaged in strengthening the safety of medicinal products and medical devices.

The 8th edition will build on the experiences from previous successful conferences presenting a program covering the current most important topics and challenges encountered within the pharmacovigilance area. Knowledgeable experts will provide excellent updates in key areas, covering recent advances in technology, science and legislation, as well as practical aspects. Sessions will be interactive and participants will be able to ask questions, engage in a dialogue and also share their own experiences.

Among others, we will cover the following topics:

  • Inspections
    • Industry and regulatory perspectives, including IT perspective
    • Current trends including special features during the pandemic
  • Medical device and combination product – the PSUR document
  • Pharmacovigilance requirements post-Brexit (e.g. PSMF)
  • Artificial Intelligence
    • AI & Machine Learning
    • AI applied in signal detection and safety data analysis
  • Outsourcing of pharmacovigilance tasks
  • Pharmacovigilance operations in Headquarters vs. Affiliate

Who should attend?
The conference program is designed for healthcare professionals or pharmacists in safety surveillance 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, sponsors, vendors and CROs, representatives from patient organizations.

Scientific Board
Wasim Anwar, Director Safety Surveillance - Biopharm, Diabetes Insulin & Devices at NovoNordisk
Caroline Sandstroem, Senior Specialist GCP/GLP/GVP, Compliance Global QA R&D at Ferring Pharmaceuticals

Doris Irene Stenver, Independent Pharmacovigilance Adviser, Founder of Unique Advice

The Conference is planned to be a one-day on-site event located in Copenhagen, unless the current state-of-play of the Covid-19 pandemic only allows for a on-line event.

Programma
09 November 2021
08:30
09:00
Registration
09:00
09:10
Welcome by the Scientific Board
09:10
09:50
Using AI/ML Algorithms in Critical GVP Applications - Points to Consider
Ib Alstrup - IT Medicines Inspector at Danish Medicines Agency

Abstract available soon

09:50
10:10
Coffee break
10:10
11:00
Digital Landscape in PV – How to apply artificial intelligence effectively?
Martin Holm-Petersen - CEO at Insife

Automation, and recently not least in the form of artificial intelligence, is subject to investments for most Pharma companies and Regulatory Agencies today. It is, however, not trivial to implement advanced automation technology effectively across the PV process landscape, i.e. to be able to harvest the potential value. In this session, we will go through learnings from the recently completed, PV-focused “AI Data Analyzer” public-private initiative and talk about how to get the most value of machine-derived data in the actual processing of ICSRs, signal detection etc. without compromising compliance. Also, it will be argued why some of the automation gains also has potential even if you are only processing smaller case volumes.

11:00
11:30
Panel Discussion and Q&A Session
Wasim Anwar - Vice President & Deputy QPPV - Head of GS Compliance, Global Safety Novo Nordisk A/S
Ib Alstrup - IT Medicines Inspector at Danish Medicines Agency
Martin Holm-Petersen - CEO at Insife

The session will be chaired by Wasim Anwar

11:30
12:30
Lunch
12:30
13:15
Medical device and combination product – the PSUR document
Mikael Juul Bygsø - Senior safety surveillance specialist at NovoNordisk

Abstract available soon

13:15
14:00
Pharmacovigilance requirements post-Brexit
Kiernan Trevett - Expert GpVp Inspector at MHRA

The UK left the EU on 31 January 2020 and the transition period ended on 31 December 2020. Initially the UK remains very highly aligned with the EU regulatory framework, free to take independent decisions in relation to Great Britain whilst remaining aligned with EU decisions in respect of Northern Ireland. This session will provide the insight of a UK regulatory authority inspector into the operation of pharmacovigilance now that the UK has left the EU and the approaches that industry has taken in implementing the updated requirements

 

14:00
14:30
Coffee break
14:30
15:10
Outsourcing of Pharmacovigilance Activities
Ea Marie Holst - Partner and Director of Pharmacovigilance at Pharma IT

 

This presentation will cover the regulatory landscape and practical considerations related to outsourcing of pharmacovigilance activities. From several years of experience working within the pharmacovigilance area in either contracting organizations or vendors/customers, Ea will highlight the present opportunities when outsourcing pharmacovigilance activities, as well as the potential pitfalls your company should be aware of. Outsourcing of pharmacovigilance activities can be a great opportunity for companies looking to fill competency gaps amongst their own staff. Through outsourcing, companies can hire the best experts for specific tasks without the hassle and expense of hiring and onboarding senior staff members. Companies should be cautious in selecting the right partner since the ultimate responsibility for pharmacovigilance lies on them. This includes due diligence to ensure you have proper procedures and contracts that cover all aspects of the partnership, as well as understanding how you can maintain a state of control when outsourcing to protect your company and its data.

15:10
15:50
PV Operations in Headquarter vs. Affiliate –Collaboration and oversight
Marie Fogh Hansen - Principal Pharmacovigilance Professional at Lundbeck

This presentation will provide examples of how a collaboration between a Global patient safety unit in Headquarter and affiliates can look like in a small-size/mid-size pharmaceutical company. It will describe how the Global unit and Global/EU QPPV are in contact with the affiliates and keep oversight of PV activities performed locally.

The presentation will cover examples from affiliates where local PV activities are outsourced and handled by a global or local vendor and affiliates where local PV activities are handled internally. Considerations about centralized handling of local PV activities vs. local handling will be shared along with the challenges and solutions that have been experienced related to centralization

15:50
16:10
Q&A session
Marie Fogh Hansen - Principal Pharmacovigilance Professional at Lundbeck
Ea Marie Holst - Partner and Director of Pharmacovigilance at Pharma IT

The session will be chaired by Wasim Anwar

16:10
16:20
Conclusions by the Scientific Board
Relatori
Wasim Anwar
Info Scientific Board

Wasim Anwar

Vice President & Deputy QPPV - Head of GS Compliance, Global Safety 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.
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.
Ib Alstrup
Info Speaker

Ib Alstrup

IT Medicines Inspector at Danish Medicines Agency
Bio available soon
Mikael Juul Bygsø
Info Speaker

Mikael Juul Bygsø

Senior safety surveillance specialist at NovoNordisk
Bio available soom
Marie Fogh Hansen
Info Speaker

Marie Fogh Hansen

Principal Pharmacovigilance Professional at Lundbeck
Pharmacist by training. Has been with Lundbeck for 3 years; 1 year in Medical Information, and 2 years in Global Patient Safety. Former Local PV experience from MI/PV role in an affiliate. Current role in the function “Local Patient Safety Support”, supporting and managing oversight of Local Patient Safety in affiliates and at vendors.  
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
Ea Marie Holst
Info Speaker

Ea Marie Holst

Partner and Director of Pharmacovigilance at Pharma IT
Ea Marie Holst is a Partner at Pharma IT, a pharma-focused consultancy that assists its clients across all key areas within the pharmaceutical, biotech, and medical device industries.  As a seasoned pharmacovigilance professional with 15 years of experience in the pharmaceutical and medical device industries, she leads the firm’s pharmacovigilance team. Ea has worked in both headquarters and affiliates with all aspects of post-marketing pharmacovigilance and clinical study safety including; Risk management, external and internal Data Monitoring Committees, Signal detection, benefit-risk evaluation, building and maintaining quality management systems, Pharmacovigilance training, E2b reporting and testing, literature monitoring, ICSR case processing and reporting, reconciliation and coding in clinical trials, complaint and medical information handling and reconciliation. She is GCP certified, as well as trained in Argus Safety and ARISg™. 
Kiernan Trevett
Info Speaker

Kiernan Trevett

Expert GpVp Inspector at MHRA
Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012 and is currently working in the role of Expert GPvP Inspector.  She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP), has had a role in the training of GPvP Inspectors in other worldwide regulatory agencies and has contributed significantly to the MHRA’s preparedness work in advance of the UK’s withdrawal from the EU.   Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials.   Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.
Contatti

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


Quote di iscrizione

€ 670,00* Early Bird fee until October 29th, 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, networking lunch, 2 coffee breaks, 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)

Edizioni Passate
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
Acquista
Early bird
Acquistabile fino al 29/10/2021
670,00
Ordinaria
Acquistabile fino al 08/11/2021
790,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 08/11/2021
430,00
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<p><strong>Park Inn by Radisson Copenhagen Airport</strong><br />
Engvej 171, 2300 Copenhagen S, Denmark</p>
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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>