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.
Ready for the new GCP ICH E6 (R2) addendum?
On the 23rd of July 2015, the EMA's Committee for Human Medicinal Products released the Guideline for Good Clinical Practice E6(R2) for consultation. On the 14th of June 2017, it will come into effect and influence everyone involved in the clinical research process. What does it mean to pharma and biotech companies, sponsors, CROs, research institutes and third-party organizations?
As a reaction to the advancements in technology over the last twenty years, the latest GCP draft represents the biggest revision of the GCP ICH guidelines since 1996. With its main objective to harmonize existing guidance from the FDA, the EMA and others, it is expected to change the way in which clinical monitoring and trial management are conducted. According to the EMA, the new guideline will provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting.
Therefore, adoption of centralized Quality Risk Management and clinical research monitoring will be vital. Its advantages should be obvious, starting with the optimization of clinical data quality, subsequently achieving time and cost savings, and risk reduction at the end.
The new GCP ICH E6 (R2) Addendum introduced 26 new items covering three main areas of clinical research: sponsor and investigator responsibilities and risk-based monitoring. How can you comply with all of them?
1. To adopt the technology and practices in order to comply with the new requirements, sponsors should gather GCP experts to determine its outcome for the company.
2. With the compliance strategy ready, the company should define areas with persistent deficiencies. This gap analysis will help them determine a plan for change and the steps needed to get there.
3. Many sponsors still use various systems for data capturing, which can easily lead to overlooking the risks. Designing one integrated system with all the data will create real-time risk monitoring across the entire trial site network.
4. Cultural transformation is one of the biggest challenges companies face. Creating a centralized approach and sharing case studies of successful switching among organizations not only can help reduce monitoring time and cut costs but also uncover new risks.
5. Besides the responsibility for the quality, safety and efficacy of the clinical trial, the sponsor should always oversee the activities of CROs to be sure its approaches will meet the new ICH requirements.
To close the gap in order to comply with the new GCP ICH E6 (R2) addendum, join the upcoming 2nd Annual Clinical Quality & Compliance conference, taking place on 14 – 15 June 2017 in Prague.
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.
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.