Services
Pharma Covigilance
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders (MAHs) have a legal obligation to set up and maintain a Pharmacovigilance system. Our team possesses appropriate knowledge and experience relating to the detection, assessment, understanding and prevention of adverse effects.
Hub Net Scientific Pharma has developed full Pharmacovigilance system as described in Good
Pharmacovigilance Practices (GVP) including all quality aspects and offers it to clients. Each company is implemented to our Pharmacovigilance System which is compliant with EU requirements.
RISK MANAGEMENT PLAN (RMP)
What is Risk Management Plan (RMP)? It is an obligatory document for each newly registered medicinal product. Its aim is, on the one hand, to characterize the safety profile of a given drug and, on the other hand, to broaden the knowledge of potential risks for the patient and to plar measures to minimize these risks.
WHAT TO LOOK FOR IN THE PREPARATION OF THE RMP?
Risk Management Plan should be prepared on a special risk management plan template published by the European Medicinal Agency (EMA). Failure to adhere to the applicable template increases the risk of comments from Competent Authorities (CAs), thus reducing the chances of a positive evaluation and obtaining a Marketing Authorization (MA).
An important element of each RM is also a list of safety concerns, divided into identified, potential and missing information risks. An MP with an appropriately adapted list of risks is a positive aspect of a medicinal product.
It is also important to carry out activities in accordance with the Harmonization of Risk Management Plan Project (HaRP), introduced in 2019, which aims to harmonize the list of risks included in the RMP. Thus, to avoid comments from CAs, the principles of the HaRP methodology should be applied to each new MP. You can find out more about it here (slide 8-11, please note that this material is in Polish language).
COLLABORATION WITH EXPERTS
Keeping track of the latest Competent Bodies requirements is much easier with the support of an experienced and well-informed team. At Science harma, we offer both the preparation of a completely new MP, or the service of updating an existing document - depending on the individual needs of the Marketing Authorization Holders. When developing an RM, we use the current definition of "risk" and the newest MP template. We ensure timely preparation of high-quality documentation, which translates into a smooth assessment and obtaining CAs approval - without unnecessary downtime and delays during the procedure.
