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Conference Documentation: Pharmacovigilance, Drug Safety & Risk Management

Conference Documentation: Pharmacovigilance, Drug Safety & Risk Management

The expansive field of drug surveillance has increased the complexity of problems across the board in relation to PV auditing and meeting the standard requirements. Companies continue to face challenges of understanding the key considerations when presenting to auditors and knowing how to adequately adapt to different regulatory environments and changes. Moreover, clarifying individual roles within the PV system is paramount to setting out clear goals and meeting regulatory expectations.

For any company looking to globalise their business, the governance of reporting adverse drug events by different centralised authorities, along with heterogeneous terminologies and competing priorities has created greater uncertainties and barriers to enter new markets. The daunting task of complying with multiple regulations also heightens the danger of unrealistic expectations as well as mounting costs and time that will have long-term implications on investment. Therefore, the importance of a centralised database has never been more vital to employ knowledge sharing and product awareness.

Join SMi in tackling these issues: 2015 will bring a focus on drug surveillance and signal detection; analysis and prevention of adverse drug reactions with MedDRA, industry experiences and global regulatory coverage of developments. Furthermore, we will cover Eudravigilance, and the growing trend of outsourcing Pharmacovigilance, as well as navigate through the challenges of compiling PSUR’s and frequent safety reports and how to adapt better to regulatory updates by preparing key areas that will be most impacted.


Day 1
8:30
Registration & Coffee
9:00
Chair's opening remarks
Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd
9:10
OPENING ADDRESS: Reaching the required performance standards of Pharmacovigilance
Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd
9:50
Reviews and infrastructure of Risk: Benefit management plans
Lesley Wise, VP Global PV Risk Management & Pharmaepidemiology, Takeda
10:30
Morning Coffee
11:00
Combining adverse events throughout clinical trials and post-marketing surveillance
Peter De Veene, Executive Director, Clinical Safety and Pharmacovigilance (CSPV), Daiichi Sankyo
11:40
SPOTLIGHT PRESENTATION: Forecasting risk through signal detection analysis
Margot Stam Moraga, Associate Director, Benefit-Risk Management , Quintiles
12:20
Networking Lunch
13:30
MedDRA: Meeting evolving Pharmacovigilance needs
Tomas Moraleda, International Medical Officer, MedDRA MSSO
14:10
Pharmacovigilance 2015 – greater integration and internationalization
Doris Stenver, Chief Medical Officer, Member of PRAC, Danish Health and Medicines Authority
14:50
Afternoon Tea
15:20
Pharmacovigilance management & risk minimisation procedures to ensure drug safety
Kashif Sheikh, Senior Safety Surveillance Advisor , Novonordisk
16:00
Risk Management through Statistical Integration
16:40
Combining adverse event monitoring and drug surveillance
Chetan Shatapathy, Director, Sanjeevani Pharma
17:20
Panel Discussion: Advocating communication to enhance risk management and intellectual property
Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd
17:20
Panel Discussion: Advocating communication to enhance risk management and intellectual property
Tomas Moraleda, International Medical Officer, MedDRA MSSO
17:20
Panel Discussion: Advocating communication to enhance risk management and intellectual property
Margot Stam Moraga, Associate Director, Benefit-Risk Management , Quintiles
17:20
Panel Discussion: Advocating communication to enhance risk management and intellectual property
Kashif Sheikh, Senior Safety Surveillance Advisor , Novonordisk
17:20
Panel Discussion: Advocating communication to enhance risk management and intellectual property
Chetan Shatapathy, Director, Sanjeevani Pharma
18:00
Chair's Closing Remarks
Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd
Day 2
8:30
Registration & Coffee
9:00
Chair's Opening Remarks
Pipasha Biswas, Executive Director & QPPV, Symogen Ltd
9:10
Cause and Effect – Striving towards proactive surveillance through innovation
Pipasha Biswas, Executive Director & QPPV, Symogen Ltd
9:50
Data integration and visualization: Boosting safety signal detection and assessment
Michael Merz, Chair Investigative Liver Expert Team, Novartis Instutes for Biomedical Research
10:30
Morning Coffee
11:00
Causality assessment of adverse drug events
Shelley Gandhi , Director of Pharmacovigilance and Drug Safety, NDA Group
11:40
European drug safety under EudraVigilance
Alistair Coates, Director, EudraVigilance Consultants Ltd
12:20
Networking Lunch
13:30
CASE STUDY: Good Pharmacovigilance (GPV) guidelines
Julia Appelskog, QPPV , Bluefish Pharmaceuticals
14:10
Vigilance and risk management of medicines
Heike Benecke, Director of Vigilance Management, MundiPharma
14:50
Afternoon Tea
15:20
Post-marketing drug surveillance
Saad Shakir, Director, Drug Safety Research Unit
16:00
Patient safety and tackling the challenges of under-reporting and patient communication
Raquel Rogers , Risk Safety lead , Pfizer Ltd
16:40
CASE STUDY 2: Risk management for well-established products assessment
Mircea Ciuca, Head Medical & Clinical Drug Safety , Vifor Pharma
17:10
Chair’s Closing Remarks and Close of Day Two
Pipasha Biswas, Executive Director & QPPV, Symogen Ltd

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