Current Challenges and Future Developments for Drug Safety in Emerging Markets
Drug safety has never been more important. Patient's attitudes to risk have changed significantly and negative perceptions of a product can have devastating effects on the reputation of the developer.
Regulatory hurdles and rule changes on risk management have also increased the pressures on drug developers to ensure sound pharmacovigilance processes are in place.
Presented by Dr. Monica Rusu Director, Pharmacovigilance EELA, Abbott Products GmbH, at IQPC's Pharmacovigilance and Risk Management Strategies in June 2010.
- The local regulatory environment and expectations of competent authorities
- Developing risk management plans to conform to differen regulatory standards
- Challenges for the global PV systems
- Identifying commonalities across the emerging markets for a more standardised approach to risk management
Have Your Say
Rate this feature and give us your feedback in the comments section below
Case Study: Design Space Development for Large Molecules in Upstream Processing Concept
Portable Quality By Design
Das Modell der EFPIA zur Verifikation pharmazeutischer Produkte
Effective Internal and External Partnerships in Oncology Trials
UCB Case Study: Open Innovation and Risk Sharing Partnerships – What are the Benefits and Practicalities?
Reviewing Recent European Cases to Implement Best Practice Patent Filing Strategies for the Future
Dealing with Changes in the Marketplace: Mergers and Acquisitions in the CRO Industry and their Impact on Sponsors
Assessing the Global Impact of Standardisation on Manufacturers: Is it Really Worth it?
Treating Asthma with Monoclonal Antibody Based Drugs: Past Experience and Future Prospects
Delivering and Sustaining Lean on the Shopfloor
* = required.
Post & Pre Marketing Pharmacovigilance in Asia by 2020: Solvay Pharmaceuticals
Dr. Rashmi Hegde, Solvay Pharmaceuticals’ Director Pharmacovigilance Asia-Middle East-Australia-Canada... Read more
Message from the Regulators: Pharmacovigilance to Move Heavily into Risk-Benefit Assessment
Pilar Carrero Director of Safety Medical Writing at Novo Nordisk, joins Andrea Charles from Pharma IQ,
ASEAN Countries will Lead Asian Pharmacovigilance Harmonisation
Dr. Suzette H. Lazo, Director of the Philippines’ Food & Drug Administration, believes that Asia... Read more