PV Services

MIT Gesundheit - PV Services

With intelligent market strategies you lead your prescription preparations as well as the OTC products to success. You want to invest in the market and not build up a staff of highly qualified PV employees that you cannot utilize to capacity with PV tasks. Our PV Services will support you.

We take responsibility away from you.

On your behalf, we fulfill your obligations to the Federal Institute for Drugs and Medical Devices (BfArM) as well as other authorities in all drug safety matters. Incoming adverse reaction reports are processed by us and forwarded to the authorities concerned within the reporting deadlines. We can also take over the future obligation to electronically submit adverse reaction reports (§ 63b AMG) to the authorities for you.

Our PV Services

We offer the following range of PV services, tailored to your company. But only if activities are actually required, we will act for you:

  • Establishment of a pharmacovigilance system (including SOPs)
  • Creation of a „Pharmacovigilance System Master File (PSMF)“.
  • Literature research (international and local literature)
  • Research on relevant websites of authorities and committees (e.g. BfArM, EMA, PRAC) regarding case reports and other PV-relevant information.
  • Evaluation and processing of the „Medical Literature Monitoring (MLM)“ of the EMA
  • Evaluation and processing of individual cases including entry into a PV database and reporting to authorities if necessary
  • Evaluation of PV-relevant publications (e.g. study reports)
  • Signal Detection
  • Writing of „Periodic Safety Update Report (PSUR)“ or „Periodic Benefit-Risk Evaluation Report (PBRER)“.
  • Preparation of „Risk management plans (RMPs)“.
  • Entry and maintenance of the „EudraVigilance Medicinal Product Diary (EVMPD)“ data
  • Position of the persons responsible for the PV (step-by-step plan representative, Qualified Person for Pharmacovigilance- QPPV) see „Responsible persons“.
  • Readability tests

Responsible Person

Every pharmaceutical company is required by European and national law to appoint persons responsible for certain tasks and to notify the authorities of their names.

Our range of services includes, among others, the position of the following legally required persons according to AMG and AMWHV:

  • Information officer (§ 74a AMG)
  • Graduated Plan Officer (§ 63a AMG)
  • Großhandelsbeauftragter (§52a AMG; §2 AM-HandelsV)
  • Quality Management Officer (§3 AMWHV)

For more information, visit our service page on Responsible Persons.

Pharmacovigilance – Further Services

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