Medical
The Medical Department provides scientific support for late stage development and post-marketing support for drugs and devices.
The Medical Department provides scientific support for late stage development and post-marketing support for drugs and devices. The Medical Department functions in close collaboration to the Marketing & Regulatory Affairs Departments.
The key activities are:
- Development of Clinical studies
- Writing Biowaiver Justifications for BCS Class I and Class III APIs
- Collaboration with experts to develop Clinical and non-Clinical overviews for product dossier submissions
- Provision of medical information to healthcare providers, consumers or business partners
- Medical Liaison for foreign partners
- Continuous support on monitoring the safety and efficacy profile of medicinal products
- Provision of scientific input and review of SmPC and Product labeling
- Translation of Medical Information texts
- Literature Search
- Pharmacovigilance
pharmacovigilance
The Pharmacovigilance System of help pharmaceuticals, is in accordance to the requirements of the existing legislation, ensuring continuous monitoring of product safety.
Both help pharmaceuticals and its affiliate companies are registered in the Eudravigilance database and expediting reporting takes place through EVWeb trader environment.
In the area of Pharmacovigilance help pharmaceuticals and its partners provide the following services:
- Provision of Qualified Person Responsible for Pharmacovigilance (QPPV) for the European Economic Area (EEA QPPV) and Deputy EEA QPPV on a 24-hour basis
- Serving as primary contact point for all local and global pharmacovigilance matters, dealing with queries made from health authorities, health professionals and customers
- provides relevant information necessary for evaluation of benefits and risks that result from the use of the medicinal product, requested by Regulatory Authorities.
- MAH registration to the Eudravigilance database
- Electronic E2B compliant medicinal product submissions to XEVMPD
- Pharmacovigilance SOPs development, maintenance and compliance monitoring
- Weekly routine plus ad hoc worldwide medical literature screening
- Management of Individual Case Safety Reports
- Preparation and submission of Periodic Safety Update Reports (PSURs) and Addendums to Clinical Overviews (ACOs)
- Monitoring of product safety
- Developing and managing safety data agreements
- Organizational issues of Pharmacovigilance department (Compilation and maintenance of Pharmacovigilance System Master File according to business needs)
- Development and regulatory authority submission of Risk Management Plans
- Preparation for Pharmacovigilance audits/inspections
- Pharmacovigilance training for personnel related to Pharmacovigilance activities
If you want to contact us to report any pharmacovigilance related issue please go to the “Pharmacovigilance”
