Date

14 October 2020

Location

Amsterdam

Language

English

Benelux Pharmacovigilance Day

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Benelux Pharmacovigilance Day

“Safety and Pharmacovigilance” increasing Awareness of Significant and Essential Needs in Benelux Countries 


The 4th Benelux Pharmacovigilance Day conference will be the opportunity to discuss, deliberate and debate the latest operational and technological challenges in the Pharmacovigilance (PV) and drug safety field. Recent advances and perspectives in PV and drug safety in clinical trials will be shared during the meeting, with an emphasis on practical aspects and how-to. This event brings together the relevant experts to share their experience in the field using practical examples. This will trigger engaging discussions and will guide participants’ efforts in the jungle of currently available methods. The objective is to help find solutions to multiple challenges that, as a cross-functional development team in PV, must solve to maximize new opportunities ahead. 

This year’s event focuses on hot topics that have major impact on Safety and Pharmacovigilance related processes and activities such as, but not limited to:

  • New inspection mood and audit feedback (PV quality compliance linked to new AI tools)
  • New medical device regulation: Impact on safety reporting
  • Safety reporting in drug-device combination  
  • AI in Literature monitoring, new tools 
  • Assessment of effectiveness of risk Minimization Measures    
  • Big Data in PV- Signal management 
  • QPPV challenge & emerging trends linked to Brexit 
  • New PV tools, Machine learning and AI (data protection and Signal detection – requirements, challenges and compliance) how to capture safety concerns?
  • Clinical Trial regulation (CLINICAL TRIALS REGULATION (EU) NO 536/2014 Q&A document) 
  • PV requirements for health supplements or alternate therapies

During this one-day forum we will provide and discuss the best solutions to help drive success in your organization.


Scientific Board

Elena Prokofyeva – Head of Drug Safety Unit at FAMHP

Leanne Walsh - Global Director, Drug and Device Safety Services at Covance

Parminder Kaur - CEO & EU QPPV at RegPak BioPharma Consulting


Who should attend?

This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care 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 Manifacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students). Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.


Sponsor

   

For sponsorship opportunities, please contact events@lsacademy.com

Certificate of attendance

Download the programme
Certificate of attendance

14 October 2020

Information found in the biomedical literature is a significant source for tracking and reporting adverse drug reactions (ADR). The EMA and FDA have both mandated that market authorization holders maintain active screening of literature for any mentions of ADRs related to their drugs or other medicinal products. Given the increasing amount of international and local literature, screening, reviewing and monitoring literature costs more time, money and creates an additional compliance risk. Embase has introduced the first local language module for French literature as step in standardizing global and local literature surveillance as a single streamlined process. However, the challenge with the amount of data to review and critically assess is still faced by all market authorization holders. To address this, we are testing the use of advanced technologies in Artificial intelligence (AI), Machine learning (ML) and Natural language processing (NLP). Our first step was to develop models to identify Adverse events (AE) in the literature. By ensuring that all relevant information is captured efficiently, the company is helping drug safety and pharmacovigilance teams deliver considerable improvements in health-critical workflows.

Michelle Mohsenin Michelle Mohsenin – PV Literature SME/Manager at Elsevier

Following the latest developments concerning the Brexit, EMA notified all the relevant stakeholders that as of 1 February 2020, “the UK will no longer be able to participate in EU institutions and their decision-making”. After the transition period, the EU Pharmacovigilance map will further change, which in turn will have a significant impact in MAHs responsibilities covering EU and UK based QPPVs and PSMFs, among the other PV tasks.

The objective of this presentation is covering the current status of QPPV and PSMF requirements reflected in the legislations, both EMA and MHRA, activities performed by MAHs, specifically referring to QPPV and PSMF, and transition period – the preparations for proper shaping of PV system. Looking into the future, this presentation will focus on the roles, and the prospect relations between EU QPPV and UK QPPV; EU vs UK PSMF – similarities/differences in format and content – what we know or do not know; and finally, what will UK PV system have in common with other ex-EU countries’ requirements in sense of having a responsible person and document describing the PV system, but never been part of the EU.

Katerina Karasarlidis Katerina Karasarlidis – Senior PV consultant, EU QPPV at ProPharma Group

Scientific Board

Parminder Kaur
Parminder Kaur CEO & EU QPPV at RegPak BioPharma Consulting
Elena Prokofyeva
Elena Prokofyeva Head of Drug Safety Unit, Dept. Research & Development, DG PRE at FAMHP, Belgium
Leanne Walsh
Leanne Walsh Global Director, Drug and Device Safety Services at Covance

Speakers

Katerina Karasarlidis
Katerina Karasarlidis Senior PV consultant, EU QPPV at ProPharma Group
Michelle Mohsenin
Michelle Mohsenin PV Literature SME/Manager at Elsevier

Scientific Board

Parminder Kaur
Parminder Kaur CEO & EU QPPV at RegPak BioPharma Consulting
Elena Prokofyeva
Elena Prokofyeva Head of Drug Safety Unit, Dept. Research & Development, DG PRE at FAMHP, Belgium
Leanne Walsh
Leanne Walsh Global Director, Drug and Device Safety Services at Covance

Sponsors

Media Partners

Conference Venue

Crowne Plaza Amsterdam - Schipol
Planeetbaan 2, Hoofddorp, 2132 HZ, Netherlands (Holland)

Crowne Plaza Amsterdam Schiphol is a 4-star hotel only a 10-minute drive from Amsterdam Airport Schiphol. This property offers a free Airport shuttle service and free parking during the stay.

  Amsterdam Airport Schiphol (AMS). Airport Shuttle is available .

  For those arriving by car to the hotel, free parking available.

  in addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
            - Hyatt Place Amsterdam Airport (at 1 km)
            - Novotel Amsterdam Schiphol Airport (at 1 km)
            - Hampton by Hilton Amsterdam Airport Schiphol (800 mt.)

Useful information


Upon Arrival
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.

Refreshments
Coffee breaks and networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.



Conference Room
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.



Informative literature
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.

Fee includes
Seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. 

Useful numbers

Francesca Archetti
Francesca Archetti Operations & Training Manager
Annalisa De Biasi
Annalisa De Biasi Project & Scientific Manager
Enrico Pedroni
Enrico Pedroni Managing Director

Past Events

Conference Price

805.00 €

Early Bird

Monday, September 14, 2020

685.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

For information:

Contacts:

Francesca Archetti
Francesca Archetti Operations & Training Manager
Annalisa De Biasi
Annalisa De Biasi Project & Scientific Manager
Enrico Pedroni
Enrico Pedroni Managing Director
Organised by

Technical and scientific training in the
pharmaceutical field
Via Roma 20 – 24022 – Alzano Lombardo (BG)
Tel: +39 035 515684

Participants' Feedbacks

Interaction during breaks is always very interesting. Presentations are clear

Very effective speakers. Good food, good location 

Met colleagues from the industry.  Heard from (new) develpments

Good Program .The combined presentations gave a good insight in current PV 

Different aspect of PV were addressed. Good diversity of speakers and background

In each topic there was some relevance to my daily work

Very well selectioned topics, presenters are experts in the area 

Perfect opportunity to have "hot topics" to discuss outside the"own environnment". Opportunity to have several topics discussing in just one day 

Good organization. Good networking possibilities

Variety of topics adressed / competency of speakers 

Very nice group!

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

Information collection and use
In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.