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Safety & Vigilance

Clinical Trials Phase II - IVNon-interventional StudiesMedical Devices

Pharmacovigilance – Clinical Trials Phase II – IV

 

The regulatory requirements for the systematic safety surveillanc of your pharmaceutical product are extensive and require profound know how.

 

Our interdisciplinary team of experts combines experience with continuous training in the current regulatory requirements. We support you with the monitoring of your pharmaceutical product in compliance with all safety requirements.

 

We provide you with the following services:

 

  • Screening of data from clinical trials for safety relevant aspects
  • Preparation and Processing of  Individual Case Safety Reports (ICSR), including  Follow-up
  • Medical Reviews
  • Entry of safety data into the sponsors’ databases
  • Electronic reporting of case reports to the relevant authorities
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Preparation of the Perodic Safety Update Report (PSUR), the Development Safety Update Reports (DSUR), monthly Safety Reports, the Risk Management Plan (RMP)

 

Your contact for Pharmacovigilance – Clinical Trials Phase II – IV

Dr. Petra Hofmann

Dr. Petra Hofmann

Petra.Hofmann@winicker-norimed.com
+49 (0) 911 / 9 26 80 8765

Pharmacovigilance – Non-interventional Studies

 

The regulatory requirements for the systematic surveillance and safety of your pharmaceutical product are extensive and require profound specialist expertise.

 

Our interdisciplinary team of experts combines experience with continuous training in the current regulatory requirements. We support you with the monitoring of your pharmaceutical product in compliance with all safety requirements.

 

We provide you with the following services:

 

  • Screening of data from non-interventional studies (NIS) and other data collections for safety relevant aspects
  • Medical Review
  • Preparation and Processing of  Individual Case Safety Reports (ICSR), including  Follow-ups
  • Entry of safety data into the sponsors’ databases
  • Electronic reporting of case reports to the relevant authorities
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Preparation of the Perodic Safety Update Report (PSUR), monthly Safety Reports, the Risk Management Plan (RMP)

 

Your contact for Pharmacovigilance – Non-interventional Studies

Dr. Petra Hofmann

Dr. Petra Hofmann

Petra.Hofmann@winicker-norimed.com
+49 (0) 911 / 9 26 80 8765

Vigilance – Medical Devices

 

The medical device industry is an innovation-oriented and rapidly developing field that is subject to continually increasing regulatory requirements. These requirements differ significantly from those in the pharmaceutical industry and affect the medical device vigilance in particular.

 

We provide you with the following services:

 

  • Screening of data from clinical investigations with medical devices
    • Case Processing for cases reported in medical device studies, incl. conduct of Follow-up procedure
    • Medical Review
  • Support with incident processing in close collaboration with your medical device safety officer
    • Processing of Line Listings (in accordance with MEDDEV 2 7/3, also for European competent authorities)
  • Entry of safety data into the sponsors’ databases or relevant (national) reporting forms
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Support with the preparation of Safety Reports

 

Your contact for Pharmacovigilance – Medical Devices

medizinprodukte@winicker-norimed.com
+49 (0) 911 / 9 26 80 0

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