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.
Back to Basics in Pharmacovigilance
Read more about pharmacovigilance and its history
Pharmacovigilance (pharmaco meaning medicine in Greek and vigilare meaning keeping watch on in Latin), or known by its more common name, drug safety, focuses on prevention, monitoring and collection of data for adverse effects of pharmaceutical products.The main objectives of Pharmacovigilance are:
- Patient care – Improve patient care and safety
- Public health – Early detection of safety problems
- Assessment of risks and benefits – Benefits, effectiveness or harm
- Communication – Promote to both professionals and the public
- Education – Public education campaigns to raise awareness and mobilize support for action are a major challenge.For PHP (public health programmes), developing countries should be a priority. According to the Uppsala Monitoring Centre, Africa’s ADR reporting capacity is weak (for example in Kenya, Zambia and Senegal). HIV, TB, immunization as well as bad infrastructure and equipment are also key issues here. The biggest WHO campaigns include 8 “World” events: World TB Day, World Health Day, World Immunization Week, World Malaria Day, World No Tobacco Day, World Blood Donor Day, World Hepatitis Day and World AIDS Day.
- Wonders of the World Wide Web – Patients, doctors, hospitals, insurers, drug companies, NGOs and patient organizations need to and want to share data.The coverage that is now available because of modern technology is a good start. But it is not only patients who are looking for information online. When making clinical decisions, physicians spend twice as much time using online resources as compared to printed materials.
- Digital Health – Patients look for information online and they are eager to share.Peer–to–peer healthcare with “tech” support that is not only rational and informational but also emotional is the key and quick responses are a must. Wearables or out–of–home means of monitoring are trending too. Smart watches, bracelets, apps for mobile phones, calorie counters, sleep pattern monitors, step counters… We could go on and on.
- Personalized Medicine – Taking variables like a patient's family and medical record history into account is already a component part of practice.What more can we do? Targeting medicines to patients’ individual genes, trends like genetic mapping, more comprehensive labeling, nanotechnology and more represent the future.
- International Harmonization – With the globalization of the market, changes in the society and rising innovation in the pharma industry, PV needs to be treated as a key public health system.There is a growing call for transparency and integration of data towards the goal of the highest ethical, professional and scientific standards in protecting and promoting the safe use of medicines. Because of individual case reports, data collection is moving more towards spontaneous reporting and new methodologies are arising.
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.