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Pharmacovigilance Services in Germany

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for overseeing post-market safety surveillance for pharmaceutical and allied Pharmacovigilance products services in Germany. Clinical trials cannot capture the entire safety profile of a pharmaceutical product since these investigations are conducted on a small number of subjects which typically do not represent the entire public with respect to medical practices. Thus, not all adverse drug reactions are shown and cannot be observed. It is these rare reactions that provide important information about the safety profile of a pharmaceutical product. Indeed, new findings associated with the safety profile of a pharmaceutical product can emerge after it has reached the market. Under the German Medicines Act, BfArM are required to continuously monitor and systematically collect & evaluate safety information for a pharmaceutical product that has obtained approval. This responsibility is of the Pharmacovigilance Division who also ensure that patients, healthcare professionals, and other stakeholders are made aware of these risks and ways to mitigate them, if applicable.

DDReg is a leading global contender within pharmacovigilance services and understands the importance of identifying crucial safety information and reporting it in a timely manner. Post market safety surveillance is a crucial part of DDReg’s pharmacovigilance services in Germany that constitute adverse drug reaction reporting, signal detection & management, development & submission of aggregate reports and risk management plans.

DDReg’s Pharmacovigilance Consulting Services in Germany include

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management plan pharmacovigilance
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling documents – i.e Prescribing Information & Medical Guides (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Qualified Person/Qualified Person for Pharmacovigilance (QPPV)/(QP)

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Retainer services for QPPV Services and Deputy
  • Local Safety Responsible
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review Audit and Compliance to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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