Dr. Christine Härer

Responsible for entering cases into Argus Safety and Clintrace.

Medical Writer Stugy Protocol and Patient Information Leaflet, Clinical Evaluation of a Type I medical device (based on literature), PSURs

Drug Safety Officer within the literature group. Responsible for identifying and evaluating adverse reaction case reports in scientific publications. Entering cases into the safety data base (Clintrace and Argus Safety).

Internship within the literature group. Responsible for identifying and evaluating adverse reaction case reports in scientific publications. Entering cases into the safety data base (Clintrace).

Beyond Simple Editing, Drug Safety for Medical Writers Part 2: Laboratory Data

Writing Clinical Study Reports using ICH E3, The Investigator's Brochure, Medical Writing and Observational Studies, Clinical Trial Disclosure for Medical Writers: Results Posting

Introduction to Pharmacokinetics, Introduction to Paediatric Investigation Plan Application, Pharmacology for Medical Writers

GCP Training for Medical Writers, Ethical Issues in Clinical Trials, The Patient Information Leaflet and European Regulatory Procedures for Medical Writers

Content: ICH-GCP, EMA Vol 9a, AMG, CIOMS, PSUR, Risk-Benefit Evaluation, EU-Harmonization, RMP, DSUR

Content: Introduction Pharmacovigilance, Guidelines, definitions of AE, ADR, SAE, SUSAR, EMA, BfarM and FDA regulations, literature cases, child cases, geriatric patients and pregnancy cases

Topics covered: National and international regulatory requirements, AMG, ICH-GCP, clinical trials, EDV, medical English, pharmacology and toxicity, statistics, project management

Thesis title: DNA double strand break rejoining by NHEJ and interfacing components

Mikrobiologie Diplomarbeit am Institut für Mikrobiologie und Genetik Abteilung Molekulare Genetik und Präparative Molekularbiologie in Göttingen Topic: Substrate preferences of the DNA mismatch glycosylase Mig.MthI