Silver Sponsors

Organized by

www.pharmariskandcovigilance.com

4TH ANNUAL

RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT12 - 14 SEPTEMBER 2017 I VIENNA

Pharmacovigilance Industry MarketGROWTH, TRENDS AND ANALYSIS

• Safety Evaluation Regulatory Affairs• Patient Support Programs• PV Inspection and Audit Readiness

12 September 2017 (15:00-16:00) The future trends

• New technologies and innovative methods in pharma-covigilance are emerging, but do you know how to utilize them?

• Dive deeper into safety and risk management issues and solutions in the EU through real-world experiences

• Enlightened evolution of regulatory science that speeds needed products to prescribers and patients

• Future strategies for growth in Pharma• Engagement of patients in the future product develop-

ment and regulatory processes• Utilize new approaches to present benefit-risk data and

communication of risk-benefit messages to health care providers, patients and consumers

12 September 2017 (16:00-17:00) Risk Minimization Measures (RMM)

• Individual consideration of each safety concern which is described in the safety specification needs

• Determining the most suitable risk minimization measure• When are you successful with your RMM?• How to measure evaluate effectiveness of RMM?• What are the contributing factors• Seriousness and severity of the potential AEs • Its preventability or the clinical actions required to

mitigate the risk

PRE-CONFERENCE WORKSHOPS

SPEAKERS PANEL INCLUDE

Luke Keitel Head of Global Quality & ComplianceAPCER Life Sciences

Magnus Nord VP Global Patient Safety CVMDAstraZeneca

Martin HenzlDirector Baxter

Heike Schoepper MD, PhD, MBAHead of GDS-PV Management, Research & Development, Global Medical Affairs and Global Drug Safety Biopharma

Jean Marie HeimMD Toxicologist, Group Medical Director, Global Pharmacovigilance and Epidemiology Bristol Myers Squibb

Katalin Timár-HorváthManaging Director

ComFit Europe Kft.

Dr.Reinhard FesharekHead of Global Clinical Safety & Pharmacovigilance CSL Behring

Jan CleerboutDirector, Medical Safety Officer Johnson & Johnson

Monika Manske Associate Director, Global Pharmacovigilance Governance, Head Pharmacovigilance Quality System Mylan

Sandra Meyer Pharmacovigilance Alliance HeadNovartis

Karsten Lollike Corporate Vice PresidentNovoNordisk

Pilar CarreroVice President, QPPV OfficeNovo Nordisk

Kristof Vanfraechem Global Head International PharmacovigilanceRoche

Felix ArellanoGlobal Head of Pharmacovigilance and Drug Safety Roche

Lydie MarcelonDeputy Director Pharmacoepidemiology and Risk Management Sanofi Pasteur

Melanie Essavez-RouletCountry Quality Oversight Lead, Global Pharmacovogilance Sanofi

Katharina HartmannHead Pharmacovigilance Vaccines Takeda Pharmaceutical Company Limited

DAY 1 Wednesday 13 September 2017

BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.pharmariskandcovigilance.com

08:20 Registration and Morning Coffee

08:50 Opening Remarks from the Chairperson

09:00 SPEED NETWORKING SESSION

Don’t forget your business cards! GREAT 15 MINUTES ICE-BREAKING AND NETWORKING ACTIVITY to meetyour peers before we start.

09:15 CASE STUDY

Innovative approach to clinical development

• Current developments in the field of dengue prevention and control

• Methods to improve dengue situation in the region

Katharina Hartmann Head Pharmacovigilance Vaccines Takeda Pharmaceutical Company Limited

10:00 CASE STUDY

Case study - New Vaccine Launch: How to improve PV awareness and reporting in low middle income countries?The introduction of a new Dengue vaccine was targeting the first launched in low and middle income countries through mass vaccina-tion campaigns. The LMIC countries have heterogeneous PV systems and some require capacity building. In this context, the ultimate objective is to avoid to jeopardize the mass vaccination campaign after launch due to a lack of information regarding the safety of the vaccine / minimize the risk of media crisis and false signal. Stimulation of AEs reporting by patients/HCP is criti-cal to further characterize the safety profile of our new vaccine in real life setting. • Implement an easy-to-use web and interactive solution

to collect the PV data from HCP through PC, tablets and smartphones.

• Set-up a prospective multi-national non-interventional post-authorization safety study consisted of a Cohort Event Monitoring using standardized data collection instruments through patient cards to be distributed to 30 000 vaccines & electronic Case Report Form to be filled in by HCPs.

Melanie Essavez-Roulet Country Quality Oversight Lead, Global PharmacovogilanceSanofi

Lydie Marcelon Deputy Director Pharmacoepidemiology and Risk ManagementSanofi

10:45 NETWORKING COFFEE BREAK

11:15 CASE STUDY

What is automation in pharmacovigilance?

Pharmaceutical companies are continually tasked with gathering more safety information and responding to evolving and often changing - requiremenets more quickly. PV organisations must decide whether their current systems for handling safety information across rely too much on manual methods. This presentation is intended as a discus-sion into the possibilities and challenges of automation in PV

• Modern work platforms are emerging on the market• Transition to automation: is that simple?• What is the organisational impact of this transformation

Pilar Carrero Vice President, QPPV OfficeNovo Nordisk

12:00 CASE STUDY Finding the optimal benefit-risk balance

• What is the expected and actual (individual) benefit for a specific patient?

• What is the weight of evidence that supports that a risk exists?

• How serious is the risk and does the risk outweigh the benefit?

• How often is it that the risk will occur and is it preventable?

• Will it decrease/disappear after a drug is stopped or will the risk increase over time?

• Are there any other treatment options where the benefit-risk balance is more favorable or less favorable?

Heike Schoepper, MD, PhD, MBAHead of GDS-PV Management| Research & Development | Global Medical Affairs and Global Drug Safety Biopharma

12:45 LUNCH

14:00 CASE STUDY

Best practices in the field of PSMF

• New regulations in emerging markets• Reviewing EU requirements• Highlighting the importance of the master file in communication• Revising techniques

Monika Manske Associate Director, Global Pharmacovigilance Governance, Head Pharmacovigilance Quality SystemMylan

14:45 PRESENTATION

Quality Assurance Auditing in PharmacovigilancePharmacovigilance has become a complex global web of regulations, systems, and partnerships. This presentation will review the current factors driving the need to be inspection-ready and the role of quality assurance auditing in demonstrating a compliant organization to regu-lators around the world.

Luke Keitel Head of Global Quality & ComplianceAPCER Life Sciences

DAY 1 Wednesday 13 September 2017

15:30 PRESENTATION

Presentation by:

Katalin Timár-Horváth Managing Director ComFit Europe Kft.

16:15 NETWORKING COFFE BREAK

16:45 CASE STUDY

Taking PV Outsourcing to the Next Level through PartnershipGrowing demands on Pharmacovigilance as well as finite resources have prompted organizations to accelerate efficiency initiatives, including the outsourcing of operational tasks and support activities. Following a value stream assessment, we took the next step: Partnership with a vendor providing the computerized system in a Software as a Service model, all case processing and most other operational support. This presenta-tion summarizes our experience in setting up this partnership and managing it for the first 18 months.

• Transformation of Pharmacovigilance at Baxter• Streamlining interfaces with vendors through partnership• Managing vendor service levels • Deploying PV applications in Software as a Service models

Martin Henzl Director Baxter

17:30 DISCUSSION

Interactive Panel DiscussionIn this session, the audience has an opportunity to ask questions and have an open interactive discussion with the discussion panellists.

• Implementing a readiness program for the Eudravigilance Upgrade • Benefits and challenges of the new system • Developing a communication plan to ensure all necessary infor-

mation is circulated

18:15 RECEPTION

Cocktail receptionAll attendees will have a great opportunity to discuss with their peers.

Magnus Nord AstraZeneca

Martin HenzlBaxter

Lydie MarcelonSanofi Pasteur

Monika ManskeMylan

Allan Lloyds provides a range of options for the relevant industry Solution Providers to par-ticipate in our events. We provide you with an unrivalled opportunity to develop mean-ingful relationships with decision makers and create a competitive advantage to gain max-imum return on investment. Showcase your products or technologies with our sponsorship possibilities accessible by all summit delegates.

ARE YOU A SOLUTION PROVIDER?

TO BOOK YOUR STAND

Contact please Mr. Sam Khalaf

on +421 221 025 324 or bus.dev@allanlloyds.com

BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.pharmariskandcovigilance.com

See Minute by Minute Programme

Connect online with other Delegates and Speakers before, during and after the Summit

Add most interesting Sessionsto your Calendar

Make the most out of your Summit networking and create meaningful business connections!

Features of Summit App

DAY 1 Wednesday 13 September 2017 DAY 2 Thursday 14 September 2017

BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.pharmariskandcovigilance.com

08:20 Registration and Morning Coffee

08:50 Opening Remarks from the Chairperson

09:15 CASE STUDY

Signal detection and strategiesOverview of requirements and methods, current issues and stakeholders Jan Cleerbout Director, Medical Safety OfficerJohnson & Johnson

10:00 CASE STUDY

The country staff as a strategic opportunity in patient centric risk management

Kristof Vanfraechem Global Head International PharmacovigilanceRoche

10:45 NETWORKING COFFEE BREAK

11:15 CASE STUDY

Learnings from PV Inspections (Europe and Arabic League)Feedback from PV inspections are part of shaping the PV systems. The presenter will discuss findings from EMA PV Inspection, especially focus on IT-systems. The presenter will also highlight major findings from global PV inspections especially in Arabic countries where new PV legislation is enforced.

• PV Inspections• EMA• Arabic League• IT-Systems• Literature Monitoring• OC of in-coming cases

Karsten Lollike Corporate Vice President NovoNordisk

12:00 CASE STUDY

Delivering Strategic Clinical Drug Safety and PhV - Learnings from AstraZenecaThe last few years AstraZeneca-MedImmune has developed the clinical drug safety and pharmacovigilance organisation to shift focus from routine license-to-operate and pharmacovigilance activities, to strategic support for decision-making for drug projects and products. This has included advancing predictive and reactive scientific approaches in drug safety, launching a new operating model and organisational structure and reducing the procedural framework over 60%, key learnings and case studies from this journey will be presented.

• Refocus from Routine License-to-operate activities to Strategic support for decision-making

• Novel Predictive Statistical methods and Mechanistic PK-PD modeling for safety

• Using Large Data Networks for Clinical Drug Safety and PhV-Risk Management

• Reducing the Procedural framework in a major global phar-maceutical company

• Off-shoring vs Outsourcing of routine safety tasks

Magnus Nord VP Global Patient Safety CVMDAstraZeneca

12:45 LUNCH

14:00 CASE STUDY

Innovation in PV

• SM as a platform for pharma companies to create awareness• Further opportunities to identify drug safety issues directly with

patients • What can be achieved with the above

Felix Arellano Global Head of Pharmacovigilance and Drug Safety Roche

14:45 CASE STUDY

Global regulatory landscape for PV – how has it evolved and where is it headed?

• Europe - EMA requiring name of qualified person (QPPV); PV system master file (PSMF) and serious adverse events to be submitted within 15 calendar days

• Will product safety become more standardized globally and how?

Sandra Meyer Pharmacovigilance Alliance Head Novartis

15:30 CASE STUDY

Benefit risk assessments during life cycle of a productThis presentation will guide you through how to establish gen-eral company-wide oversight and consistency in benefit risk assessments during life cycle of a product starting from early stage development until post- approval space.

• Different situations where structured benefit : risk frame-work can help and support good decision making, from go / no-go decisions, stage gate decisions, risk management decisions etc.

• What elements do we ideally include in benefit: risk dis-cussions / decisions, what data do we need to generate and how we integrate different perspectives (individual patients, populations, health authorities, payers, company, etc.)

Dr. Reinhard Fesharek Head of Global Clinical Safety & Pharmacovigilance CSL Behring

DAY 2 Thursday 14 September 2017

BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.retailbankingsummit.com

16:15 CASE STUDY

Successful risk-benefit assessment

Jean Marie Heim MD Toxicologist, Group Medical Director, Global Pharmacovigilance and Epidemiology Bristol Myers Squibb

17:00 NETWORKING COFFEE BREAK

17:30 DISCUSSION

Interactive Roundtable DiscussionAll attendees will have a great opportunity to discuss a selection of the most interesting topics addressed during the conference in small groups with their peers. Every table will nominate a head of table, which will summarize the topic discussed, present the main puzzles, and questions posed.

PV perspectives• Justifying the use of additional risk minimization tools when rou-

tine measures cannot ensure the favourable benefit-risk ratio of a medicine

• The process of planning and implementing additional risk minimisation tools or programs

• these measures should facilitate and strengthen the cooperation between the patient and the physician as much as possible

• Use of process and outcome indicators• Applying of additional measures that may be used simultaneously

making up a complex program

All AttendeesDiscuss with your peers and share knowledge

18:15 CLOSING REMARKS FROM THE CHAIRPERSON

Allan Lloyds is the leading provider of the most diversified business intelligence events. Quality has always been our priority and we understand every industry is unique with different needs and chal-lenges. We turn events into a unique experience based on interaction, discussions and networking. Today, we are trusted by senior experts within Fortune 500 companies as a top business enrich-ing interaction event provider. Our summits bring in a diverse group of speakers and initiate sessions on topics going beyond any usual case studies.

These summits can change the course of your business and lead to a sustainable relation between your company and customers.

VENUE VIENNA

Things to do in Vienna:

• No visit to Vienna is complete without a visit of this magnificent palace –Schoenbrunn Palace. The gardens are a must.

• Did you know Vienna also has a Walk of Fame? Instead of containing celebrities like in LA, this walk of fame is full of composers who had some sort of connection with Vienna.

• Visit massive cathedral is the true centerpiece of Vienna - St. Stephen’s Cathedral

I am looking forward to welcoming you personally at the Risk Management and Pharmacovigilance Summit in September!

Sidonia JamborovaProduction Manager

BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.pharmariskandcovigilance.com

PLEASE FILL IN REQUIRED DETAILS IN BLOCK AND FAX or E-MAIL TO:Fax: +421 252 444 225 / e-mail: sam.khalaf@allanlloyds.com

Sales Contract Conference Code AL-P-16

BOOKING LINE: Tel.: +421 221 025 324 / Fax: +421 252 444 225 www.pharmariskandcovigilance.com

CONFERENCE PRICE

PER DELEGATE

Two Day Conference € 3 500

Conference Registration / Terms and ConditionsPayment terms: After completion and return of the registration form, full payment is required within 5 days from receipt of invoice. Entry may be refused to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. There is a 50% liability on all bookings once made, by fax or email. A no refunds policy exists for cancellations received on or after one month before the event. Should you decide to cancel after this date the full invoice must be paid. However, if you cannot attend the conference, you may make a substitution (colleague) at least one week before first day of the event, as long as we are informed in writing by email or fax. Name changes and substitu-tions must be from the same company. Allan Lloyds Group (AL EVENTS s.r.o.) reserves the right to alter the conference content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Allan Lloyds Group (AL EVENTS s.r.o.).(Force Majeure: meaning any circumstances beyond the control of Allan Lloyds Group (AL EVENTS s.r.o.), including without limitations to any Act of God, governmental restrain, fire, tempest, strike or lock-out (other than by Allan Lloyds’ own employees or agents), war or act of terrorism. We strongly advise all our conference clients to take out travel insurance.The conference fee includes refreshments, lunch and conference material for the event. This fee does not include travel, hotel accommodation, transfers or insurance, (which Allan Lloyds strongly recommend you obtain). We may store and process your information for administrative purposes and to better understand your needs and how we can improve our products and services. In addition, we may use that information to contact you.Please complete the registration form in full so that we can contact you and provide you with our best services.

DELEGATE DETAILS

Mr./Ms.

Name

Job Position

e-mail

Mr./Ms.

Name

Job Position

e-mail

Mr./Ms.

Name

Job Position

e-mail

Mr./Ms.

Name

Job Position

e-mail

Mr./Ms.

Name

Job Position

e-mail

PAYMENT METHOD

Name of Card Holder

Card Billing Address

Signature

Name

Signature Date

COMPANY DETAILS

Organisation

Address(Street, City)

Post Code

Country

Phone

VAT number

Card Number:

VISA Master Card Euro Card AMEX Diners Club

Last 3 (three) digits on the back of the card:

Card Security Code (AMEX) :

/Valid From: Expiry Date: (mm / yy)

/

I, the signatory, am authorized to sign on behalf of the contracting organizations and agree to AL EVENTS debiting my credit card.

I confirm that I have read and agree to the terms and conditions of booking.

SALES CONTRACT

Upon registration we shall issue you an electronic invoice. If you require a hard copy of the invoice please tick here

Conference Fee Payment is required within 5 working daysPrices are excluding VAT, an Austrian VAT 20% will be applicable.

BOOKING LINE: Tel.: +421 221 025 322 / Fax: +421 252 444 220 www.pharmariskandcovigilance.com