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.
Meet your quality and compliance goals with Fleming.
COMPLYING with quality requirements is a must for a scientifically & ethically valid clinical trial. Globalization, outsourcing and the increasing complexity of clinical trials has resulted in a novel compliance scenario regarding international quality standards for clinical trials.
To make it easier for you to meet regulatory expectations and quality standards for every clinical trial, Fleming. has decided to organize the Clinical Quality & Compliance Masterclass.
Experts from Pfizer, Roche, Sanofi, Boehringer Ingelheim, AstraZeneca, Bayer and others will gather on 16 – 17 June 2016 in Vienna, Austria to discuss how to manage clinical quality for greater compliance, effectiveness & audit readiness.
During the two interactive days, attendees will have the opportunity to gain practical tips from a GCP inspector during an on-stage interview, get deeper insight into key drivers of clinical quality under the recent GCP guideline amendments, explore new approaches to auditing investigator sites with a risk-based monitoring model, ensure the sponsor accountabilities in the quality oversight in an outsourced model, and much more.
Participants will have the opportunity to work on practical tasks and share their results on winning tactics & strategies for achieving the highest quality, cost efficiency and operational excellence during three built-in workshops.
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.
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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.
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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.