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www.glceurope.com | [email protected] | + 36 1 848 0515
www.glceurope.com
02-03 March 2017Crowne Plaza Berlin - Potsdamer Platz, Germany
Shreya DavéDirector, Pharmacoepidemiology Takeda Pharmaceuticals Europe United Kingdom
Dr. Belal NaserHead of Pharmacovigilance | QPPVSchaper & Brümmer Germany
Dr. Maria Teresa HerdeiroProfessor, Medical Sciences Department/ Professor, Director of Diagnosis and Therapeutic Technologies DepartmentUniversity of Aveiro / CESPU crl.Portugal
Dr. Karen Cheng - Heil FFPMSafety Medical Director of Antibiotic Business UniteAstraZeneca United Kingdom
Rudi ScheerlinckHead Global Drug SafetyBasilea Switzerland
Bert Van LeeuwenDeputy Qualified Person forPharmacovigilance (QPPV)Astellas Pharma EuropeThe Netherlands
Among the Speakers
• PV as “science and art” Listen to industry experts discussing the current pharmacovigilance ladscape within Europe
• Pharmacovigilance and the BREXIT Learn more about the impact of BREXIT on PV within Europe
• Artificial Intelligence in PV Understand how AI will change the ecosystem of PV
• Medical literature monitoring Discuss the main impacts of EMA’s medical literature monitoring service
• Signal Detection Gain an insight on the regulatory guidance on signal detection
• PASS and PIP Hear the best practices in design and conduct of PASS and PIP
Hot Topics
For more information speak to us at the event or visit:
Premium Event Partner
At Comfit we have been monitoring literature with the purpose of pharmacovigilance since 2009. We aim at reviewing all local medical journals in Europe. We use standardised working procedures across countries and combine human power with our validated software: medical professionals review while our software make reports and store data. With our integrated method, we will not miss any of our clients’ medicinal products.We also monitor the websites of Medicine Agencies daily. We look for updates in regulatory guidelines and news, highlighting the precise changes and record them in our VigIntelligence database. With our reports, our users can spare time and work while being well-informed without being overwhelmed with information.
Andrew A. ParsonsExperienced Scientist, Executive Leader, Coach, Trainer and Supervisor. Co-author of Leading with Presence United Kingdom
Day 1 Chair
Khaudeja BanoSenior Medical Director, Medical Device Safety Head AbbVieUnited States of America
Stéphanie Tcherny-LessenotPharmacoepidemiology GEM & Genzyme LeadSanofiFrance
Day 2 Chair
Dr. Steinar MadsenMedical Director, Department of Drug InformationNorwegian Medicines Agency Norway
www.new.vigintelligence.com www.comfiteurope.eu
www.glceurope.com | [email protected] | + 36 1 848 0515
5th Annual Pharmacovigilance Forum
Exclusive Speaker Line-up
02-03 March 2017Crowne Plaza Berlin Potsdamer Platz, Germany
Prestigious Advisors
Ioan MagyarAssoc.Prof. of Basic & Clinical Pharmacology Faculty of Medicine & PharmacyOradea University - Romania
Manfred Hauben Senior Director, Risk Management StrategyPfizer Inc - United States
Anca MicleaSenior Specialist Medical Safety & EpidemiologyAbbott Laboratories – Germany
Anne GramkowHead of Safety and QPPV Pharmacosmos – Denmark
Bert Van LeeuwenDeputy Qualified Person for Pharmacovigilance (QPPV)Astellas Pharma Europe - The Netherlands
Media Partners
Shreya DavéDirector, Pharmacoepidemiology Takeda Pharmaceuticals Europe United Kingdom
Dr. Belal NaserHead of Pharmacovigilance | QPPVSchaper & Brümmer Germany
Stéphanie Tcherny-LessenotPharmacoepidemiology GEM & Genzyme LeadSanofiFrance
Rudi ScheerlinckHead Global Drug SafetyBasilea Switzerland
Bert Van LeeuwenDeputy Qualified Person forPharmacovigilance (QPPV)Astellas Pharma EuropeThe Netherlands
Andrew A. ParsonsExperienced Scientist, Executive Leader, Coach, Trainer and Supervisor. Co-author of Leading with Presence United Kingdom
Dr. Steinar MadsenMedical Director, Department of Drug InformationNorwegian Medicines Agency Norway
Souzi MakriPresident/ Chairperson/ FellowENFA/AGORA/EUPATI - Cyprus
Mariska Kooijmans-Coutinho Head of Drug Safety and Pharmaco-vigilance International and EU QPPVAmicus Therapeutics United Kingdom
Antonella BacchieriHead of Pharmacovigilance Department, Deputy EU QPPVSigma-Tau Industrie Farmaceutiche Riunite S.p.A.Italy
Mircea CiucaHead Medical & Clinical Drug SafetyVifor PharmaSwitzerland
Dr. Niraj ChhayaRisk Management, Global PharmacovigilanceBiosimilar PortfolioBoehringer Ingelheim GmbH Germany
Khaudeja BanoSenior Medical Director, Medical Device Safety Head AbbVieUnited States of America
Dr. Karen Cheng - Heil FFPMSafety Medical Director of Antibiotic Business UniteAstraZeneca United Kingdom
Phillip EichornSenior Director Pfizer Pharmaceuticals United Kingdom
Dr. Doris TaeschnerLocal Pharmacovigilance ManagerBoehringer Ingelheim Switzerland
Katalin Tímár - HorváthManaging DirectorComFit Europe Ltd Hungary
Day 1 Chair
Day 2 Chair
Dr. Maria Teresa HerdeiroProfessor, Medical Sciences Department/ Professor, Director of Diagnosis and Therapeutic Technologies DepartmentUniversity of Aveiro / CESPU crl.Portugal
www.glceurope.com | [email protected] | + 36 1 848 0515
5th Annual Pharmacovigilance Forum
02-03 March 2017Crowne Plaza Berlin Potsdamer Platz, Germany
Past Delegates include
www.glceurope.com | [email protected] | + 36 1 848 0515
5th Annual Pharmacovigilance Forum
08:30 Welcome Coffee and Registration
08:45 Greeting from the Project Leader & GLC Icebreaker Session
08:55 Opening Remarks from the Chair Andrew A. Parsons Experienced Scientist, Executive Leader, Coach, Trainer and Supervisor. Co-author of Leading with Presence United Kingdom
09:00 Pharmacovigilance in the light of BREXIT • How did BREXIT affect the European Pharmacovigilance landscape?• What will the future brings• Regulatory changes• New challenges
Q & A Session Rudi Scheerlinck Head Global Drug Safety - Basilea - Switzerland
09:40 An overview of EMA MLM’s method of literature monitoring • On what conditions marketing authorisation holders can rely on MLM • Challenges of literature monitoring
Q & A Session Katalin Tímár - Horváth Managing Director - ComFit Europe LTd - Hungary
10:20 Switzerland- still a special country; Tips for an successful Pharmacovigilance Inspection
• Differences between Switzerland and EU: ICSR Reporting, Signal Management, PSUR - PBRER, Risk Minimization
• Inspection preparation: preparation and areas of interest during the inspection
Q & A Session Dr.Doris Taeschner Local Pharmacovigilance Manager Boehringer Ingelheim - Switzerland
11:30 Practical advice on the planning and conduct of Pharmacovigilance audits in small and medium-sized enterprises (SMEs)
• How to be best prepared for an audit, especially in SMEs. • Practical advice on the planning and conduct of audits in SMEs • Management of audit procedures, outcomes and findings
Q & A Session Dr. Belal Naser Head of Pharmacovigilance | QPPV Schaper & Brümmer - Germany
12:10 Current regulatory trends in PASS and PIP studies • Best practices in design and conduct of PASS • Regulatory background for preparation• Practical view and case studies of harmonization and requirements• Collection of real-world data
Q & A Session Shreya Davé Director, Pharmacoepidemiology Takeda Pharmaceuticals Europe – United Kingdom
12:50 Effectiveness Evaluation of Risk Minimization Measures: a Case Study
• General overview on implementing risk minimisation measures and assessing their effectiveness
• Sigma-tau experience with a centrally registered product at EMA • Challenges in measuring effectiveness of risk minimization
Q & A Session Antonella Bacchieri Head of Pharmacovigilance Department, Deputy EU QPPV Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. - Italy
14:30 Reclassifying medicines for OTC: Assessing benefit-risk and risk minimization in a consumer setting
Stéphanie Tcherny-Lessenot Pharmacoepidemiology GEM & Genzyme Lead Sanofi - France
15:10 Human Factors – Optimising the usability of processes and technology in Pharma R&D
• Human Factors – what are they?• Increasing usability and productivity• Reducing errors• Human Centred Organisations• Patient Safety
Q & A Session Andrew A. Parsons Experienced Scientist, Executive Leader, Coach, Trainer and Supervisor. Co-author of Leading with Presence United Kingdom
16:20 Why does pharmacovigilance sometimes fail and where could the fault lie?
• Risk blindness - industry or drug authorities? • It’s not my fault – but whom to blame?• Hard to detect adverse reactions• Do we learn from previous experiences?
Q & A Session Dr. Steinar Madsen Medical Director, Department of Drug Information Norwegian Medicines Agency - Norway
17:00 Pharmacovigilance of Antibiotics• How to plan for surveillance in products with changing benefit profile
Q & A Session Dr. Karen Cheng-Heil FFPM Safety Medical Director of Antibiotic Business Unite AstraZeneca - United Kingdom
17:40 Closing Remarks from the Chair & Networking
17:50 End of Day 1
11:00 Tea, Coffee, Networking & Exhibits
15:50 Tea, Coffee, Networking & Exhibits
13:30 Luncheon & Networking
Luncheon together with Speakers, Panelists, & Delegates with an exclusive Buffet Lunch spread
02-03 March 2017Crowne Plaza Berlin Potsdamer Platz, Germany
DAY1
www.glceurope.com | [email protected] | + 36 1 848 0515
5th Annual Pharmacovigilance Forum
12:50 Luncheon & Networking
Luncheon together with Speakers, Panelists, & Delegates with an exclusive Buffet Lunch spread
13:50 Pharmacovigilance for Biosimilars• Current practices for Traceability and Interchangeability• Safety monitoring of biosimilars: During Clinical Development and
Postmarketing phases• Current regulatory guidance on pharmacovigilance for biosimilars
Q & A Session Dr. Niraj Chhaya Risk Management, Global Pharmacovigilance Biosimilar Portfolio Boehringer Ingelheim GmbH - Germany
14:30 Significance of outsourcing and its effectiveness• Why is outsourcing on the rise?• Can we detect patterns in outsourcing?• How do we ensure a mutually beneficial relation with vendors?
Q & A Session Mariska Kooijmans-Coutinho Head of Drug Safety and Pharmacovigilance International and EU QPPV Amicus Therapeutics United Kingdom
15:40 Safety Alerts: An Observational Study• Alerts published by national authorities• New data on safety profiles• Safety measures
Q & A Session Dr. Maria Teresa Herdeiro Professor, Medical Sciences Department/ Professor, Director of Diagnosis and Therapeutic Technologies Department University of Aveiro / CESPU crl. - Portugal
16:20 Holistic Approach to Combination Product Safety • The paradigm - What are Combination Products • Global approach to combination products• Key Challenges • Risk-based approach to combination product safety
Q & A Session Khaudeja Bano Senior Medical Director, Medical Device Safety Head AbbVie - United States of America
17:00 Closing Remarks from the Chair & Farewell Networking
17:10 End of Day 2
11:00 Tea, Coffee, Networking & Exhibits
08:30 Tea, Coffee, & Networking
08:50 Opening Remarks from the Chair Bert Van Leeuwen Deputy Qualified Person for Pharmacovigilance (QPPV) Astellas Pharma Europe - The Netherlands
09:00 Signal Detection and Eudravigilance• Regulatory guidance on signal detection • Advantages and disadvantages of quantitative v qualitative
signal detection• Best practices in process optimization• Validation and confirmation of quality data• Web-based (social media) signal detection
Q & A Session
Bert Van Leeuwen Deputy Qualified Person for Pharmacovigilance (QPPV) Astellas Pharma Europe - The Netherlands
09:40 Signal Management - revised GVP guidance • New concepts and terminology• Adaptation of existing signal management process• Communication (what, when, how)
Q & A Session Mircea Ciuca Head Medical & Clinical Drug Safety Vifor Pharma - Switzerland
10:20 Web-based signal detection • Paradigm shift toward web-based signal detection: regulatory landscape• Methods for web-based signal detection, or lack thereof• Public-private partnerships to develop web-based signal detection system• Results from Sanofi projects on Web-based signal detection
Q & A Session Stéphanie Tcherny-Lessenot Pharmacoepidemiology GEM & Genzyme Lead
Sanofi - France
11:30 Pharmacovigilance : The patient Perspective• Why is Pharmacovigilance important for patients• How are patients educated to contribute to R&D of medicines • AGORA , EUPATI • Cooperation with EMA • Suggestions • Next steps
Q & A Session
Souzi Makri President/ Chairperson/ Fellow ENFA/AGORA/EUPATI - Cyprus
12:10 Safety aspects of Patient Support Programmes and other Customer Engagement Activities
• Why should the role of PV colleagues be in these activities?• What are the regulatory expectations?• How to mitigate safety-related issues.• How to promote quality of safety-related information from
these programmes Q & A Session
Phillip Eichorn Senior Director Pfizer Pharmaceuticals - United Kingdom
15:10 Tea, Coffee, Networking & Exhibits
02-03 March 2017Crowne Plaza Berlin Potsdamer Platz, Germany
DAY2
www.glceurope.com | [email protected] | + 36 1 848 0515
5th Annual Pharmacovigilance Forum
02-03 March 2017Crowne Plaza Berlin Potsdamer Platz, Germany
Upcoming GLC eventsBANKING, INSURANCE & FINANCE
• 5th Banking & Insurance Internal Audit Forum May 2017
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PHARMACEUTICAL
• PP&R 6.0 (6th Annual Pharma Pricing & Reimbursement Forum) September 2017
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HUMAN RESOURCES
• 7th HR Minds Forum June 2017
• 8th HR Minds Forum September 2017
Who will you meetSenior Pharmacovigilance ExpertsRegulators and InspectorsPharmacovigilance and Drug Safety OfficersRegulatory Affairs OfficersClinical Risk-Benefit GroupsLocal Medicines AuthoritiesCRO and Consultants providing QPPV Services
» Pharmacovigilance Team Leader» Drug Safety Officer» Global Drug Safety Officer» Pharmacovigilance Manager» Head of Safety and» Pharmacovigilance» Pharmacovigilance Consultants» Senior Safety Specialist» QPPV personnel» Regulatory affairs Associates» Regulatory Affairs Manager» International PV auditors» Lead Safety Scientist
