Date

5 - 6 October 2020

Location

Milan

Language

English

European Epidemiological Forum

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European Epidemiological Forum

The value of Real-World Evidence in Drug Life Cycle: promises, barriers and pathways to success


Regulators, health technology assessment (HTA) bodies, academics, bio-pharmaceuticals companies, payers, and patients are presently rethinking the healthcare ecosystem and facing diverse and increasing challenges at different levels. In this conceptual modelling of the healthcare ecosystem, the potential value of Real-World Data (RWD) for decision making has never been more relevant.
Real-World studies seek to provide complementary evidence to that provided by randomized controlled trials. While the latter provide evidence of efficacy, Real-World Data provide information on therapeutic effectiveness in a real-world practice setting.

Pharmaceutical companies need to focus on innovative and targeted therapies both due to the increased competition in the sector, and of the number of better structured and demanding patients’ groups or associations. Pharmaceutical companies are presently discussing on:

  • How does RWD contribute to translational research?
  • Whether there are any companies optimally leveraging RWD and how its application to biobanks can better advance innovation and discovery of targeted therapies?
  • What are the structural and logistical needs for this to be effective?
  • What have we already learned about the process?


Regulatory bodies face the challenge of ensuring that only safe and effective medicines reach patients; a decision which so far has only been substantiated upon data from RCTs. They actually need to know:

  • Whether other stakeholders can help them in the process and how?
  • Where and how do we using RWD in the drug development and approval process?
  • What has already been achieved in the field and what the success factors are? 


Payers, and HTA bodies want to make sure that the most innovative and novel medicines reach patients who need them most as quickly as possible; and that these medicines provide value for money to all parties: patients and health care systems. They may ask themselves:

  • How can sponsors better demonstrate the value of their innovative medicines using RWD?
  • How can they work with decision-makers to establish agreed upon standards for RWE research?
  • How do recent frameworks (FDA, NICE, etc) help advance RWE research?   

What brings all stakeholders at the same level is the need for new paradigms for a more performing healthcare ecosystem that reduce the gap between its representation and its implementation. Emerging e-health models and applications can greatly contribute to it, particularly, if hand-in-hand with Real-World Data Studies.

The European Epidemiological Forum will review the progress and perspectives on the value of RWD in the drug life cycle, will discuss what RWD promises, what the barriers may be and what a successful story may look like. 


Scientific Board:

Christian Agboton - Sr Global Brand Medical Director at Takeda
Maurille Feudjo Tepie - Observational Research Director at Amgen
Michele Intorcia - Health Economics Outcomes Research CoE Head at Vifor Pharma


Who should attend?

The conference is addressed to professionals with a deep interest in drug development, healthcare decision making, academia and healthcare research, belonging to department such as: Medical Affairs, R&D, HTA/Market access, Medical Informatics, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics and Data Management from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.


For sponsorship opportunities, please contact events@lsacademy.com

Certificate of attendance

Certificate of attendance

5 October 2020 | PRE-CONFERENCE WORKSHOP

Half-Day Workshop 13:00 - 17:45


Design and Implementation of Real-World Evidence Methods to Deliver Value to Physicians and Payers

A workshop to learn and understand what RWE could bring that no other method can 


Introduction

You may have heard that Real-World Data (RWD) is the next big thing, but where do we start if we want to ride the wave of RWD driven change?
In order to be able to design and actually implement the specific tools and methodologies to collect Real-World Evidence (RWE), we first need to understand the benefits and limitations of these data. Knowing how both, clinicians and payers, make use of RWE helps us in defining appropriate scenarios and avoiding common pitfalls. Learn how to assess your success, change and implement a strategic plan!


Who should attend?

This workshop is aimed at people working in the pharmaceutical industry or in the related fields with an interest on practical aspects of real-world data collection and analysis. 


Programme

  • Introduction to RWE and objectives of the workshop
  • Designing a successful strategy both for Clinicians and Payers:  Preparing participants to use the toolbox
  • First group: Prepare your tactics to fill the gap for clinicians, and present them to the others
  • Second group: Prepare your tactics to convince payers, and present them to the others
  • Feedback from the trainers: what could be improved?
  • First group: Fine tune second group’s project. Second group: fine tune first group’s project
  • Lessons learned and conclusion


Language:
The workshop will be in English


Agenda

13:00 - 13:30         Participants registration
13:30                      Course commences
15:15 - 15:30         Coffee break
17:30 - 17:45         Q&A and Conclusion


Teaching methods

The workshop is designed with a very pragmatic approach to implement real-world evidence strategies. This is an interactive training based on different scenarios. Participants will have to design and build an approach to collect and analyse Real-World Data under the supervision of the trainers.
Participants are kindly asked to bring their own computer/tablet.


Lecturers

Christian Agboton Sr Global Brand Medical Director at Takeda
Christian J. Agboton currently serves as Senior Global Brand Medical Director at Takeda based in Zurich, Switzerland. He previously served as Medical Director of Biosimilars Immunology / inflammation at Sandoz and Hospira/Pfizer. Christian also worked at GSK vaccines, Merck Serono and UCB Pharma in Clinical and Medical Affairs roles. Channeling innovation to deliver evidence while keeping quality and timelines has always been at the heart of his approach to data generation. Christian is Fellow of the Royal Faculty of Pharmaceutical Medicine (FFPM).


Maurille Feudjo Tepie
Observational Research Director at Amgen
Dr. Maurille Feudjo Tepie is an Observational Research Director at Amgen and leads the Amgen European Team of the Centre for Observational Research. Prior to joining Amgen in 2009, he spent six years in the Worldwide Epidemiology Department at GSK. Maurille obtained his PhD in Medical Statistics from the London School of Hygiene and Tropical Medicine and then completed a one year post-doctoral fellowship working on a collaborative methodological project between the Worldwide Epidemiology Department of GSK and the London School of Hygiene and Tropical Medicine, under the supervision of Profs Stuart Pocock and Steven Evans. He has considerable experience designing and executing appropriate observational research strategies to inform drug development and drug commercialisation and; is a keen contributor to scientific discussions pertaining to the challenges and/or opportunities offered to regulators, payers, academics, prescribers and to the bio-pharmaceutical industry by advances in computing science and the increased availability of real world data. He has been active in European-wide initiatives aimed at improving biomedical research (IMI PROTECT and EMIF) and is also the chair of the PSI Epidemiology Special Interest Group.


At the end of the workshop, you will be able to: 

  • Design and use the tools specific to Real-World Evidence
  • Understand the benefits and limitations to Real-World Data
  • Use 2 different approaches (for physicians, and payers) gathering elements important to deliver your pre-established strategy
  • Avoid pitfalls by consulting experts and assessing you chances of success 

More details coming soon

Scientific Board

Christian Agboton
Christian Agboton Sr Global Brand Medical Director at Takeda
Maurille  Feudjo Tepie
Maurille Feudjo Tepie Observational Research Director at Amgen
Michele Intorcia
Michele Intorcia Health Economics Outcomes Research (HEOR) CoE Head at Vifor Pharma

More details coming soon

Scientific Board

Christian Agboton
Christian Agboton Sr Global Brand Medical Director at Takeda
Maurille  Feudjo Tepie
Maurille Feudjo Tepie Observational Research Director at Amgen
Michele Intorcia
Michele Intorcia Health Economics Outcomes Research (HEOR) CoE Head at Vifor Pharma

Conference Venue

Novotel Milano Nord Ca Granda
Viale Suzzani 13, 20162 – Milano

Situated centrally, just a few minutes' walk from Ca Granda metro station, the modern 4-star Novotel Milano Nord Ca Granda hotel is in an ideal location for business trips and conferences, but also as a base for sightseeing in the center of Milan.
The lilac metro line connects the 4-star Novotel Milano Nord Ca' Granda hotel to the Milano Porta Garibaldi train station, the San Siro stadium and the Porta Nuova and Isola districts (with their impressive buildings such as the Bosco Verticale towers).


  2 minutes walking from the metro station Lotto (M1 red line or M5 violet line).

  Milan Linate airport, 12 km from Novotel, is the most closest airport to the city and can be easily reached by car, bus or train.

  Central Station 3 km, Garibaldi Station 4 km.

  On-site parking with a fee

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

Ilaria Butta
Ilaria Butta Events & Training Executive
Enrico Pedroni
Enrico Pedroni Managing Director
Valeria Quintily
Valeria Quintily Project & Scientific Manager

Past Events

Conference Price

1345.00 €

Super Early Bird

Monday, July 6, 2020

1090.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

For information:

Contacts:

Ilaria Butta
Ilaria Butta Events & Training Executive
Enrico Pedroni
Enrico Pedroni Managing Director
Valeria Quintily
Valeria Quintily Project & Scientific Manager
Organised by

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

Participants' Feedbacks

Very focused and "hot topics" of RWE generation

Interesting topics. Speakers very well prepared and with interesting talks

Do this again! Superb agenda!

Nice combinations of theory and practical issues 

Deep insight of speakers during round table, nice discussion topics. Broad view with presentations/speakers, multiple relevant topics

Enough time for networking and discussion. Very well organized

Broad coverage of topic matter & subject matter experts from various countries backgrounds. Objective of conference achieved.

Mix of industry and academia/public. Good practical examples, illustrations to mark the point

Different point of view from HTA agency, interesting examples, NICE, to market access

Very interactive, focus, practical and very relevant

Perfect timing and location

Great presenters, lot of topics covered

Very good speakers!

I found EPI Forum latest conference very focus and targeted, yet still with the right amount of generalities that should better help appreciate the lessons that could be learned from these case examples. The size (not too big!) was also very conducive to interactions and thus some kind of brainstorming sessions.

Congratulations for the great organisation of the event and the high level of the speakers. I really enjoyed the meeting!

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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

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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
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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).

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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.