AGENDA 

Day 1, 14th October- Virtual

09:55

Terrapinn's Opening Remarks

10:20

Keynote Sponsor

Uwe Gudat
10:40

Pharmacovigilance: Back to the future – returning to our roots

Sub-themesIs pharmacovigilanceprimarilya data management discipline?Is more of the same more, or less?Who are our real customers and what do they really need?Towards knowledgeable action and actionable knowledge
11:00

Questions + Answers

AI + Automation
11:10

Terrapinn's Remarks

Quality Assurance and Compliance
11:10

Terrapinn's Remarks

Case Processing
11:10

Terrapinn's Remarks

Case Processing
11:15

Presentation

AI + Automation
11:35

Sponsor Presentation

Risk Management
11:35

Risk based auditing

Maha Saad, Americas Pharmacovigilance Head, Bioresearch Quality And Compliance, Quality Assurance, Johnson & Johnson
Case Processing
11:35

Sponsor Presentation

Lykke Bjerglund Graff
13:00

PV Departments: From a cost and compliance centre to a scientific and value adding function

13:40

Platinum Sponsor

AI + Automation
14:00

Open source technology in supporting safety

Lionel Van Holle, Safety Surveillance Lead, UCB
Quality Assurance and Compliance
14:20

Building in quality to ensure "getting it right first time"

Leona Houghton, Senior Director, Global Head Pharmacovigilance Quality And Compliance, Jazz Pharmaceuticals
Translational Safety
14:40

Autoantibodies; a novel class of markers for immune-related adverse events

Richard Brennan, Scientific Advisor, Sanofi
Hans-Dieter Zucht, Group Technical Director, Oncimmune
Quality Assurance and Compliance
15:00

Live Q+A: Quality Assurance & Compliance

AI + Automation
16:20

Live Q+A: AI + Automation

Quality Assurance and Compliance
16:20

Live Q+A: Quality Assurance & Compliance

rave harpaz
16:40

Roundtables

rave harpaz, Senior Director Research and Data Science, Oracle Health Sciences
Michael Braun-Boghos, Senior Director Safety Strategy, Oracle Health Sciences
last published: 14/Oct/20 08:25 GMT

Day 2, 15th October- Virtual

Panel discussion
10:00

PV Departments: cost and compliance centre to a scientific and value adding function

10:40

Keynote Sponsor Presentation

11:00

Plenary Q+A

Risk Management
11:10

Terrapinn's Remarks

Signal Detection
11:10

Terrapin's Remarks

RWE + Big Data
11:10

Terrapinn's Remarks

Risk Management
11:15

Local implementation of additional Risk Minimization Measures

Stollenwerk Ariane, Germany, Switzerland, Austria Safety Leader, UCB
Signal Detection
11:15

Management of end to end safety variation: signal to label.

Vishakha Oza, Senior Scientist, Nerve Care Franchise, Procter & Gamble
Signal Detection
11:35

Sponsor Presentation-Reserved for Rx Logix

RWE + Big Data
11:35

Sponsor Presentation

RWE + Big Data
11:55

Guidance on digital activities

  • Multi-morbidities
  • The Cumberlege report
  • Collaboration with a medical school on appropriate prescribing
Risk Management
12:35

Live Q+A: Risk Management

Signal Detection
12:35

Live Q+A: Signal Detection

RWE + Big Data
12:35

Live Q+A: RWE & Big Data

round tables
12:55

Roundtables

Application of blockchain in the pharmaceutical industry and pharmacovigilance
Kate Gofman

Kate Gofman, Global Safety Physician, Artificial Intelligence And Blockchain Innovator, AstraZeneca

Local Implementation of Risk minimisation activities
John Solomon

John Solomon, Head Of Pharmacovigilance, Sanofi

Signal Detection for Orphan Drugs (quantitative vs qualitative approaches)
Marco Sardella

Marco Sardella, Chief Pharmacovigilance Officer And Q.P.P.V. For Europe, Adienne

Signal detection in small to medium-sized companies
Rudi Scheerlinck

Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Galderma

Mike R Cohen
13:45

Chair's Remarks

Mike R Cohen, President, Institute for Safe Medication Practices
Aman Wasan
13:50

Enabling Expedited Adoption of Technology in Pharmacovigilance

Panel discussion
14:10

Keynote Panel: Medication Error Prevention

Santiago Garnica Velandia, Drug Safety Coordinator, VITALIS SACI
Lubna Merchant, Associate Director of of Division of Medication Error Prevention and Analysis of OSE of CDER of FDA, F.D.A. Quality and Regulatory Consultants Llc
Mike R Cohen, President, Institute for Safe Medication Practices
PV Outsourcing
14:55

Terrapinn's Remarks

Risk Management
14:55

Terrapinn's Remarks

Signal Detection & Management
14:55

Terrapinn's Remarks

PV Outsourcing
15:20

Real world data: are you sure you have the relevant data?

Dominique Hamerlijnck, Patient Experience Expert, Innovative Medicines Initiative
Risk Management
15:20

Title TBC

Peter De Veene, Qppv, Alexion Pharmaceuticals
PV Outsourcing
16:00

Live Q+A: PV Outsourcing & Patient Advocacy

Risk Management
16:00

Live Q+A: Risk Management

round tables
16:20

Roundtables

Developing a map for clinical device safety and how to cover all aspects (workshop exercise)
Sylvie Bartus

Sylvie Bartus, Safety Global Clinical Affairs Director, Edwards Lifesciences

Digital therapeutics: How Older Adults can benefit from Technical Innovations
Antonia K Coppin-Renz

Antonia K Coppin-Renz, Director, Therapeutic Area Lead Digital Therapeutics And Deputy EU QPPV, Otsuka Europe

How are companies utilising development RMP’s?
Philippa Evans

Philippa Evans, Safety Medical Writer, Novo nordisk

How Digital Transformation will Change Outsourcing Trends within Pharmacovigilance
Leveraging new technologies for better signal detection and management – the role of AI, big data, and predictive analytics
Michael Braun-Boghos

Michael Braun-Boghos, Senior Director Safety Strategy, Oracle Health Sciences

last published: 14/Oct/20 08:25 GMT

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