Date

13 - 14 May 2020

Location

Madrid

Language

English

International Pharmacovigilance Day

Register Now
International Pharmacovigilance Day

A Global Pharmacovigilance Network: Opportunities or Threat?


LS Academy is delighted to welcome you to the 2nd International Pharmacovigilance Day to be held on 13th & 14th May 2020 in Madrid, Spain. The pharmacovigilance world is undergoing a phase of rapid change with new technologies, dynamic regulations and increasing complexity in data sources. This one-and-a-half day event will showcase renowned international speakers addressing hot topics in pharmacovigilance and highlighting the opportunities and challenges in managing them. Among the main topics of the day: 

  • Pharmacovigilance in first-in-human trials & monitoring guideline 
  • Safety regulations affecting device-drug and drug-device combination products
  • New PRAC strategy for impact assessment of pharmacovigilance: with focus on the strategy to measure impact of pharmacovigilance
  • Digital Health: New initiatives 
  • WEB-RADR & new technologies 
  • Electronic Product Information & e-label
  • Developing effective global PV systems 
  • Risk Management: How to stay compliant with increasing complexity 

A pool of International subject matter experts will share the floor to address the challenges phased by pharmacovigilance experts on a daily basis. 

«An Industry and Health Authorities’ perspective at our PV International Day; PV experts presenting hot-topics on safety and pharmacovigilance at an international scale», PV Scientific Committee.

Participants will have the opportunity to take part in up-to-date discussions and to share their own experiences within a greatly qualified international environment. The PV International most attractive traits include:

  • A Scientific Committee guaranteeing updated and strictly scientific topics, quality discussions and absence of any commercial presentations
  • Different international perspectives presented over the event: regulatory authorities, industry, CROs, Universities
  • Open discussions and group working sessions
  • Notable networking opportunities
  • An easy to access venue and friendly environment

An event is fully designed for professionals involved in safety, pharmacovigilance, clinical research, development and management of pharmaceutical and combination products. 

LS Academy, leader in the field of scientific continuing education, welcomes you to an outstanding International Pharmacovigilance event for constant professional development and up-to-date discussions in this extremely relevant scientific area.



Scientific Board

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

Jabeen Ahmad, Indipendent Pharmacovigilance Consultant

Pilar Carrero, QPPV Office Vice President at Novo Nordisk A/S

Rebecca Webb, Director of Pharmacovigilance Quality Assurance at AbbVie 


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

Brochure and Certificate

Download the programme
Certificate of attendance

13 May 2020

The Medical Device Directive is phased out by May 2020. That means that at the day of the convention in Madrid, the Medical Device Regulation (MDR, Regulation (EU) 2017/745) is active in full force. All companies that have a medical device on the EU market have to comply with the regulation. That also applies to companies that have a combination product on the market or in development phase. 

This will affect the required documentation necessary for product registration (technical file, Annex II, MDR) but is also affecting the company procedures. Article 10, paragraph 9 dictates which processes require a documented procedure. Note (22) of the MDR indicates that following the ISO13485:2016 is highly desirable. When combining these requirements with article 117 of the MDR regarding combination products, it becomes clear that “pharma” companies with a combination product, become subject to the above. 

Since focus on clinical evidence is increased under the MDR, this will not only affect the clinical evidence collected before product registration but it will also affect the vigilance processes. The pharmaco vigilance processes that are quite often followed for combination products, should also comply with the requirements for medical device vigilance. 


Jan Bart Hak Jan Bart Hak – Head Medical Device Team at ProPharma Group

In this presentation 2 main themes will be covered:

  • An overview of the mandate and activities of the Pharmacovigilance Risk Assessment Committee (PRAC)
  • The PRAC strategy to measure impact of pharmacovigilance

The EU pharmacovigilance system has been strengthened significantly following the implementation of the comprehensive renewed legislation in 2012. There are many indications, that the EU pharmacovigilance network is robust and effective. However, it is desirable to widen the knowledge base with regard to the effectiveness of regulatory interventions. This is the main objective with the recently launched PRAC strategy on impact assessment. The key components of the strategy, examples of impact studies and guidance for impact research will be presented.

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

Whenever a Marketing Authorisation Holder (MAH) is in control of a digital media, such as an app, the MAH has an obligation to regularly screen data entered in this app. The obligation to screen is enforced to ensure that safety information related to the use of the MAH’s product is captured, considered and reported if constituting a valid case. The frequency of screening should allow for cases to be reported to the Health Authorities within the regulatory submission timelines. 

Digital health apps have become increasingly accessible for users and the many data entered in the apps may potentially increase our knowledge on actual use and experience with medicinal products and devices, ultimately resulting in improvement of products and better medicines to patients.

The increasing amount of safety information received via such apps, however, have left room for several challenges. The incoming data must be treated in accordance with GVP requirements, in compliance with GDPR, and at the same time ensuring that patient safety is in focus.  

In addition to the safety compliance considerations, attention to customer service and technical support are also needed.

This presentation provides one approach and considerations related to the handling of safety information received via digital health apps. 

Birgitte Scharling Birgitte Scharling – Pharmacovigilance Policy Expert at Novo Nordisk

14 May 2020

Current trends for – often misaligned - local pharmacovigilance regulations, multiple CRO/partner engagements, and the raise of digital health make managing pharmacovigilance across the globe an increasingly difficult task. The role of drug safety professionals is changing with demands to balance operational excellence, compliance and oversight across the global pharmacovigilance system. 

This session will provide some examples on current challenges, and how current regulatory, societal and technology environments are shaping the future of PV professionals.


Pilar Carrero Pilar Carrero – QPPV Office Vice President at Novo Nordisk A/S

The role of patients is more important than ever. An empowered patient likes to engage more with its health and has rising needs for trusted information. They are researching for their symptoms and are taking greater control of the treatment of their disease. Due to modern technologies patients are no longer satisfied with static pdfs of patient leaflets on the web - they want information about their medicines that takes advantage of all the options available with modern technology they have at home and sharing their own experiences. How are we going to handle this challenge? How can we make important information for patients and Pharmacovigilance more easily accessible, improve its readability and allow for an interactive communication? Is there an opportunity for new ways of measuring risk minimization activities?

The session will talk about the importance of changing the existing static information into something flexible, and addressing rising use cases while connecting the dots between the different stakeholders. It will touch upon the current discussion on European level, highlight some ongoing initiatives and explore potential benefits based on use cases.


Rüdiger Faust Rüdiger Faust – Head Telematics & Digital Solutions at Grünenthal GmbH

Scientific Board

Jabeen Ahmad
Jabeen Ahmad Independent Pharmacovigilance Consultant
Pilar Carrero
Pilar Carrero QPPV Office Vice President at Novo Nordisk A/S
Doris Stenver
Doris Stenver Independent Pharmacovigilance Adviser, Founder of Unique Advice
Rebecca Webb
Rebecca Webb Director of Pharmacovigilance Quality Assurance at AbbVie

Speakers

Nikolai Brun
Nikolai Brun Chief Medical Officer at Danish Medicines Agency
Mircea Ciuca
Mircea Ciuca Global Head Medical & Clinical Drug Safety at Vifor Pharma
Rüdiger Faust
Rüdiger Faust Head Telematics & Digital Solutions at Grünenthal GmbH
Jan Bart Hak
Jan Bart Hak Head Medical Device Team at ProPharma Group
Birgitte Scharling
Birgitte Scharling Pharmacovigilance Policy Expert at Novo Nordisk

Scientific Board

Jabeen Ahmad
Jabeen Ahmad Independent Pharmacovigilance Consultant
Pilar Carrero
Pilar Carrero QPPV Office Vice President at Novo Nordisk A/S
Doris Stenver
Doris Stenver Independent Pharmacovigilance Adviser, Founder of Unique Advice
Rebecca Webb
Rebecca Webb Director of Pharmacovigilance Quality Assurance at AbbVie

Conference Venue

The location will be available soon

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

1250.00 €

Super Early Bird

Thursday, February 13, 2020

940.00 €

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

Participants' Feedbacks

Time of talks and Q&A well organized

Relevant and clear topics

Nice overview of current development in PV

Interesting topics, great speakers and high-level attendees

Positive Aspects: clarity and time of presentations; variety of topics

Many innovative topics

Great current and hot topics; high quality of speakers

Inclusion of global perspective; attendance of people from multiple backgrounds

Variety of presentations, great discussions

Agenda interesting and relevant for nowdays challenges

Excellent organisation of the event

Conference well organized and topics relevant

Excellent variety of topics; very knowledgeable speakers

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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

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. 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, or hostilities.

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.