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.
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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.
Driving the national agenda of Medical tourism through PX Excellence
Read the interview with Dr. Layla Al-Marzouqi, Director of Medical Tourism Council at Dubai Health Authority, and learn how to enrich patient experience and quality of healthcare.
No more trouble with dangerous good shipments
Global temperature controlled pharmaceutical shipments are constantly faced with new logistics challenges and regulations. This January 2017, IATA Dangerous Goods Regulations added further complexity to shipping cold chain products compliantly.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.