The WHO describes pharmacovigilance as the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem” and to that extent, the practice has been around for over 170 years,
While pharmacovigilance goes back to the time when the medical community first began to understand treatment side effects, in the last few decades practices and systems across the globe have changed rapidly. This is largely due to technological innovations as well as the massive amounts of data that has become available for biopharmaceutical companies and competent authorities to review and analyze. Of course, the increased importance of a patient-centric approach has also shifted pharmacovigilance practices; pressure placed on compliance in the pharmaceutical industry has drastically increased during this time.
Recent trends in Pharmacovigilance:
- Drug approval reviews and safety documentation has necessarily become more complex due to the ever-increasing volume of data that is collected.
- Increased public awareness about adverse drug reactions has made drug safety an even greater priority.
- Increased safety concerns have led to worldwide requirements for more detailed product information. Companies are now under far more pressure to publicly display all their safety-related data in a transparent way.
The challenge of Pharmacovigilance in 2021:
Now more than ever, biopharmaceutical companies are in need of powerful and requirement-compliant systems that can streamline the processes involved in pharmacovigilance. Outsourcing makes sense, as a dedicated team of highly experienced industry professionals are able to make the process more efficient and effective. And yet companies must look for cost-effective ways to maintain all the different aspects of pharmacovigilance infrastructure in order to remain competitive. This is where pharmacovigilance partners come in.
When outsourcing pharmacovigilance, there are a number of things you need to take into consideration:
- You should choose a partner who can provide a range of pharmacovigilance services as well as one who keeps track of industry changes and adapts their systems and practices accordingly.
- You must ensure that your pharmacovigilance partner will provide a dedicated and responsive contact for you to reach. Smooth communication is key when patient safety is at stake.
- You should ensure that your pharmacovigilance partner has a zero-tolerance attitude towards mistakes as well as a record that backs this up.
- Dokumeds offers a wide range of pharmacovigilance solutions from complete to separate functional services. We always assign a dedicated and highly experienced team to a project.
- Dokumeds consistently ensure the highest standards of patient safety at every stage of the drug lifecycle.
- Dokumeds is a CRO with over 25 years of industry experience. We stay on top of ever changing regulatory demands and can guide you through them with ease.
The pharmacovigilance team at Dokumeds consists of several highly skilled medical professionals and is led by Kerstin Fleischer, a drug safety expert. Kerstin has over 20 years of managerial experience in the industry and is dedicated to building efficient communication lines and setting up the correct priorities.