Pharmacovigilance and Risk Management

Importance of Pharmacovigilance has grown significantly over recent years and its proper implementation is essential to the success of an organization. Managing product risks effectively is one of the biggest business challenges for the Health Care Industry. Dr. Ebeling & Assoc. GmbH offers the complete pharmacovigilance service for companies or works on individual project modules, either ad hoc or on an ongoing basis.

Qualified Person for Pharmacovigilance (QPPV)

According to EU-law, the provision of a QPPV responsible for overall pharmacovigilance is mandatory for Market Authorization holders. Our QPPVs are fully experienced in all aspects and functions of EU-QPPV - like establishing, maintaining and overseeing the MAHs entire PV system and the safety profiles of the company’s products.

PV systems provide oversight of the MAH’s safety systems, processes and procedures and are eventually aiming at patient’s safety. Putting a company’s pharmacovigilance system into practice requires a systematic, practical and logical approach and Dr. Ebeling & Assoc. GmbH is well versed to put these mechanisms in place. This includes the preparation or validation of the Detailed Description of Pharmacovigilance System (DDPS) or, in future, the PV System Master File – a legal requirement in the EU.

We manage compilation, review and submission of aggregate reports for regulatory authorities on your behalf. Dr. Ebeling & Assoc. GmbH has staff with great subject matter expertise in the preparation of PSURs/ASRs according to regulatory requirements.

Dr. Ebeling & Assoc. GmbH is able to support the full case management process. This service includes data entry, MedDRA coding, causality assessment and triaging, preparation of follow-up or nullification reports and expedited reporting to authorities. It entails the processing of ICSRs originating from various sources (eg. spontaneous reports, literature reports, clinical trial reports). We carry out full quality control on each report and our trained staff has extensive experience in submission and receipt of ICSRs and SUSARs.

We operate a fully validated drug safety database which is E2B compliant and provides all the functionality required to meet your regulatory obligations and efficiency challenges. Dr. Ebeling & Assoc. GmbH can offer you an immediately available and cost effective system, removing the need for expensive installation and set-up of your own database in house. The safety data is hosted in a secure environment with appropriate back-up and disaster recovery programmes in place.

According to EU legislation (Volume 9A) significant changes to the benefit-risk ratio of a product must be reported to the Competent Authorities. Dr. Ebeling & Assoc. GmbH is able to run and review data listings for your products, helping you with the assessment of the benefit-risk ratio or work out a signal detection process tailored to meet your needs.

MAH’s are obliged to screen the world-wide literature for safety data to identify potential risks of their products. Dr. Ebeling & Assoc. GmbH performs literature review on behalf of many clients. The literature search strings undergo constant internal revision by qualified staff.

We can help you to avoid delay in product registration due to inadequate risk management. Dr. Ebeling & Assoc. GmbH has experience in the preparation and evaluation of Risk Management Plans (RMPs) to comply with European Standards, as well as creating Risk Evaluation and Mitigation Strategies (REMSs) to satisfy US requirements.

The quality documentation required for pharmacovigilance systems and activities is extensive. Compliance with company SOPs is extremely important and you have to ensure all personnel involved in pharmacovigilance receive adequate training on these SOPs. To fulfill regulatory obligations you must have a quality assurance system – fit for purpose and compliant with EU legislation. The Dr. Ebeling & Assoc. GmbH can assist you with the implementation of a structured quality management system in drug safety, regulatory affairs and medical affairs.

Pharmacovigilance inspections by Regulatory Authorities have become increasingly intensive. Prepare your staff and company for these potential inspections with our system audits and find out if you meet regulatory obligations. Dr. Ebeling & Assoc. GmbH performs independent audits to evaluate pharmacovigilance processes within your company as well as audit verification of your Quality Management System. Using external auditors permits efficient use of internal resources.