The major objective of this course is to provide a detailed insight into the practical aspects and approaches of process scale-up for different unit operations and technologies.
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?
Targeted Drug Delivery
Gain detailed overview of the newest strategies in drug delivery and targeting.
Next Generation Antibody Therapeutics
This focused 2-day training will cover the discovery, engineering and production of next-generation antibodies, antibody fragments, bispecific Abs, innovative ADCs and more. Follow the path from their discovery and selection through engineering and expression to production and regulatory issues.
White Paper: Beyond the Cold Chain
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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?