Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
The expanding role of pharmacovigilance and risk management
A profound and accelerated transformation of the Pharmacovigilance world is happening, due to several key drivers. The absolute necessity to ensure that patients can benefit from an early access to new drugs, while ensuring an optimal identification and management of risks is vital.
The regulatory world is rapidly evolving to shorten the review and approval process, moving toward more conditional approvals with restricted and controlled drug use. The field of combination products, with the limitless possibilities of smartphones, device technology, sensors and drug delivery systems is exploding. The ability to access massive datasets across different systems and populations is disrupting the existing approaches to data mining and pharmacoepidemiology.
The customization of benefit-risk at the individual level brings patient engagement activities and risk communication to a totally different way of thinking about benefit-risk and risk communication. In the meantime, the ever increasing dis-harmonization of safety requirements across regions and countries obliges pharmacovigilance organizations to constantly look for innovation, productivity and performance gains. These are some of the significant but very exciting challenges that makes pharmacovigilance such a fascinating domain, more than ever. The ability to understand the current trends and to brainstorm with key opinion leaders and colleagues are critical to preparing our minds and practices to this changing world.
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Dr. Asma Ibrahim Al Mannaei, Director, Healthcare Quality Division | HAAD
Strategize your Risk Management Plan in 2 steps
Read below the interview with Judy to reveal the latest trends in risk management and find out what are the most important steps towards strategizing your risk management plan.
A prescription of Quality and Efficiency in the right doses
Read below the interview with Ronan to understand the importance of balance between quality and efficiency and reveal which pitfalls to avoid.