Home Health Survival Strategies for Successful Pharmacovigilance Inspections

Survival Strategies for Successful Pharmacovigilance Inspections

by Louise W. Rice
124 views

Since its conception as far back as 170 years ago, Pharmacovigilance remains a crucial phenomenon in the drug development process. While seeking to uncover the side effects of drugs administered to patients, the medical community discovered the pharmacovigilance concept.

The pharmacovigilance systems and practices have undergone rapid transformation in the last decade, courtesy of technological advancements, shift towards patient-centric care, and enormous and comprehensive data to be reviewed and analyzed. ¹In doing so, the pharmaceutical industry is increasingly under pressure to overcome the above challenges while developing quality and safe drugs.

Key Trends in Pharmacovigilance

The enormous data in the modern pharmaceutical industry is complicating the safety documentation and drug approval process.

There is increased attention towards drug safety by the stakeholders in the drug development and approval process due to the increased public awareness about the side effects of the drugs.

Drug developers and regulatory authorities are increasingly providing detailed information on drugs due to increased safety concerns by the public. Drug manufacturing companies have no option but to display safety-related information on their products.

Challenges experienced by the Pharmaceutical Industry

Pharmaceutical companies are increasingly becoming under intense pressure to uphold the safety of patients during the drug development process. To do so, they require time, financial resources, and expertise, especially from experienced industry professionals. Consequently, companies are exploring ways to prioritize such demands while upholding the pharmacovigilance cro infrastructure and remaining competitive.

Outsourcing pharmacovigilance

  • To achieve successful pharmacovigilance outsourcing, there is a need to consider the following factors:
  • Choose a competent partner who understands the industry trend and adapts seamlessly to the industry changes.
  • Because patient safety is a priority, select a responsive and reliable partner who is reachable and communicates effectively.
  • Choose a partner who pays attention to detail and has zero tolerance for mistakes.

About Dokumeds:

  • Dokumeds offers a broad range of pharmacovigilance solutions to its clients, ranging from separate to complete functional services. The company assigns you competent and highly experienced professionals to address all your concerns.
  • We prioritize safety and therefore enact systems that ensure the highest standards throughout the drug development process.
  • With over 25 years of industry experience, we deeply understand the industry trends and institute innovative mechanisms that conform to the changing regulatory framework and guide you appropriately.

Dokumeds has a pharmacovigilance team of highly skilled medical professionals led by Kerstin Fleischer, a drug safety expert. With over 20 years of managerial experience in the pharmaceutical industry, Kerstin has a deep knowledge of industry trends and operations. Book a quick call today to find out how Dokumeds can streamline your pharmacovigilance infrastructure.


Author Bio: Janis Brix, CEO Wigwam.

More Articles To Read