Program: November 26

 

  Link to the online platform
09:10

Welcome and Opening remarks by the Chairperson of EUPV Congress

Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV ADIENNE Pharma & Biotech

09:20

A word from the Editor-in-Chief of Therapeutic Advances in Drug Safety – EUPV Congress Media Partner

Arduino Mangoni, Professor and Head, Dep. of Clinical Pharmacology, School of Medicine,
Flinders University, Australia

SESSION I – UPDATE FROM INTERNATIONAL PHARMACOVIGILANCE ORGANIZATIONS
09:30

Updates from the CIOMS

Hervé Le Louët, CEO of the WHO collaborative center for International Drug Monitoring (UMC), President of CIOMS, Past President of ISOP, Past Member of PRAC

09:50

Updates from ISoP

Jan Petracek, ISoP Advisory Board at International Society of Pharmacovigilance

10:10

Updates from the Uppsala Monitoring Centre

Daniele Sartori, Pharmacovigilance Scientist- Uppsala Monitoring Centre DPhil student in Evidence-Based Medicine, University of Oxford

10:30

Updates from PIPA

Sarah Hall, HonFPIPA, Managing Director MIPSOL

10:50 Q&A Time
11:00 Coffee Break e Networking
SESSION II – SIGNAL DETECTION & EVALUATION
  Chairperson of the session:
Fabio De Gregorio,
V.P., Head of Drug Safety Europe at Shionogi Europe
11:20

Signal detection and dissemination to members of the WHO Programme for International Drug Monitoring

Daniele Sartori, Pharmacovigilance Scientist- Uppsala Monitoring Centre DPhil student in Evidence-Based Medicine, University of Oxford

11:40

Translating Pre-Marketing Adverse Drug Reactions and Signal Evaluation To The Routine Management of The Older Patient: Challenges and Opportunities

Arduino Mangoni, Professor and Head, Dep. Of Clinical Pharmacology, School of Medicine, Flinders University, Australia

12:00

Post marketing Signal detection – case studies

Glyn Belcher, CEO of PV Consultancy Ltd

12:20 Round table and Q&A Time
Moderator: Fabio De Gregorio
Participants:
G. Belcher, PV Consultancy Ltd
M. Ciuca, Area Head – Global Clinical Safety and Pharmacovigilance at CSL Behring
A. Mangoni, Flinders University, Australia
D. Sartori, Upsala Monitoring Center
D. Stenver, Indep. PV Adviser Founder of Unique Advice
12:50 Lunch & Networking
SESSION III – DIGITAL & TECHNOLOGY INNOVATION IN PV: OPPORTUNITIES FOR PATIENTS
  Chairperson of the session:
Valentina Mancini, Director PV, EU QPPV, Shionogi Europe
13:50

Intelligent automation in Pharmacovigilance

Juergen Schmider, President Drug and Device Vigilance Consulting LLC – Arisglobal

14:10 Round Table and Q&A Time
Real World Evidence in PV, with digital tools for self-reporting by patients
Moderator: Valentina Mancini
Participants:
J. Schmider, Arisglobal
S. Cazzaniga, Medical Affaire Excellence Head – Janssen-Cilag Italy
S. Hall, HonFPIPA, Managing Director MIPSOL
P. Kruger, Expert patient Eupati
B. Van Leeuwen, Deputy-QPPV – Astellas Pharma Europe
SESSION IV – DRUG INDUCED LIVER INJURY (DILI)
  Chairperson of the session:
Hervé Le Louët
, CEO of the UMC, President of CIOMS Past President of ISOP, Past Member of PRAC
14:40

Drug Induced liver injury: from pre-clinical to post-marketing studies

Marco Tuccori, Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa

15:00

Pick a DILI – class effects

Glyn Belcher, CEO of PV Consultancy Ltd

15:20

Nimesulide Case Study: an example of Benefit-Risk Assessment and EU Referral Procedures

Mario Bertazzoli, Director, Group Head of Drug Safety and Reference Physician to EU QPPV at Helsinn Healthcare SA

15:40 Round Table & Q&A Time
Moderator: Giovanni Furlan, Pfizer
Participants:
M. Bertazzoli, Helsinn Healthcare SA
H. Le Louët, CIOMS
M. Tuccori, University Hospital of Pisa
16:00 Coffee Break e Networking 
SESSION V – CLINICAL TRIALS REGULATION
  Chairperson of the session:
Mircea Ciuca, Global Therapeutic Area Head – Global Clinical Safety and Pharmacovigilance at CSL Behring
16:20

CTFG Q&A RSI and CTR Q&A documents: what will change in terms of safety in clinical trials when CTR is in place?

Elena Prokofyeva, Head of drug safety Unit, DG PRE Autorization/Division R&D (Humain) Federal agency for medicines and health products – Bruxelles

16:40 Round Table and Q&A Time
Moderator: Mircea Ciuca, CSL Behring
Participants:
E. Di Martino, Scientific Director PHARMA D&S
M. Forstner, Senior Director, Pharmacovigilance & Patient Safety – PRA Health Science
E. Prokofyeva, Head of drug safety Unit – AFMPS
A. Traversa, Independent PV Expert
17:10

Marco Sardella – Chairperson’s closing remarks
Chairperson of the EUPV congress

Program: November 27

  Link to the online platform
09:00

Welcome and Opening remarks by the Chairperson of EUPV Congress

Marco Sardella, Chief Pharmacovigilance Officer & EU QPPV ADIENNE Pharma & Biotech

09:10

A word from the Editor-in-Chief of Therapeutic Advances in Drug Safety – EUPV Congress Media Partner

Arduino Mangoni, Professor and Head, Dep. of Clinical Pharmacology, School of Medicine, Flinders University, Australia

SESSION VI – COMMUNICATION IN DRUG SAFETY
  Chairperson of the session:
Michael Forstner, Senior Director, Pharmacovigilance & Patient Safety – PRA HEALTH SCIENCE
09:20

Labelling

Barbara De Bernardi, Vice President, EU QPPV – Pfizer

09:40

Paradoxic effects of communicating information on adverse drug reactions

Giovanni Furlan, Safety Risk Lead Director, Pfizer

10:00  Q&A Time
SESSION VII – PHARMACOEPIDEMIOLOGY & RISK MANAGEMENT 
  Chairperson of the session:
Doris Stenver, Indep. PV Adviser, Founder of Unique Advice
10:10

RMP weaknesses and their evolution – Effectiveness of Risk minimization actions

Jan Petracek, ISoP Advisory Board at International Society of Pharmacovigilance

10:30

Systematic Lifecycle Benefit-Risk Management and Decision Making

Michael Forstner, Senior Director, Pharmacovigilance & Patient Safety –  PRA HEALTH SCIENCE

10:50 Coffee Break & Networking
11:15 Round table and Q&A Time
Moderator: D. Stenver
Participants:
G. Belcher, PV Consultancy Ltd
F. De Gregorio,V.P. Head of Drug Safety Europe, UK QPPV- Shionogi Europe
M. Forstner, PRA Health Science
J. Petracek, Board Member ISoP
P. Rotunno, Pharmacovigilance Consultant
SESSION VIII – EUDRAVIGILANCE/EVDAS UPDATES
  Chairperson of the session:
Francoise Dumas Sillan, VP Head of Therapeutic area oncology – endocrinology Global patient safety, Ipsen
11:45

EVDAS-ISO IDMP- E2B R3

Calin Lungu, MDMRQA, BCPM, Eudravigilance and XEVMPD – EMA, CEO, DDCS

12:15 Round table and Q&A Time
Moderator: F Sillan
Participants:
L. Boga, QPPV, Dompé Pharmaceutical
C. Lungu, CEO DDCS
J. A. Ayala Ortiz, PVpharm CEO
M. D’Antuono, Corporate PV Director, EU QPPV, Italfarmaco
12:45 Lunch & Networking
SESSION IX –  PV QUALITY SYSTEM
  Chairperson of the session:
Fernanda Ferrazin, Indipendent Pharmaceutical Consultant, EuPV congress  Scientific Board, PEC
13:50

PV System Inspection Readiness

Raj Bhogal, Sr. Director, R&D Audits & Inspections – Jazz Pharmaceuticals

14:10 Round table and Q&A Time
Moderator: Fernanda Ferrazin
Participants:
R. Bhogal, Sr. Director, R&D Audits & Inspections – Jazz Pharmaceuticals
G.N. Castiglione, EU QPPV & Director Global Pharmacovigilance – Chiesi
I. Grisoni, Sr. Director, EEA QPPV – Jazz Pharmaceuticals
D. Marcozzi, Head of R&D QA – Fidia Farmaceutici
SESSION X – LOCAL VS GLOBAL PV REGULATIONS 
  Chairperson of the session:
Valentina Mancini,
Director PV, EU QPPV Shionogi Europe
14:40

Is the limelight of PV regulation moving back to national?  How to maintain global PV compliance with different/conflicting national regulations?

Bert Van Leeuwen, Deputy QPPV of Astellas Pharma

15:00

Getting the most from Patient Support Programmes – from a Safety Perspective

Phillip Eichorn, Senior director, Pfizer Pharmaceuticals

15:20

Management of global PSMF: compliance with local requirements

Margherita D’Antuono, Corporate PV Director, EU QPPV, Italfarmaco

15:40 Round Table & Q&A Time
Moderator: V. Mancini
J.A. Ayala Ortiz, PVpharm CEO
M. D’Antuono, Italfarmaco
P. Eichorn, Pfizer Pharmaceuticals
I. Grisoni, Sr. Director, EEA QPPV, Jazz Pharmaceuticals
S. Hall, HonFPIPA, Managing Director MIPSOL
B. Van Leeuwen, Astellas Pharma
16:10

End of the Congress
Marco Sardella,
Chief Pharmacovigilance Officer & EU QPPV ADIENNE Pharma & Biotech

 

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