Expertise

Indications (selection)

Allergology

Dietary Supplements

Herbal Medicines

Immunology (Vaccines)

Medical Devices

Oncology

Orthopedics

Pediatrics

Urology

Aesthetic Medicine


Current EU Regulations, Drug and Medical Device Laws, GCP Training


Medical Writing Workshops of the European Medical Writers Association

 

Since 2018: Member of American Medical Writers Association

Since 2015: Member of European Medical Writers Association

 

 

WS: Introduction to Combination Products in the US and EU

WS: How to Handle Advisory Board Meetings

 

WS: Introduction in Pharmacokinetics

WS: Post-Market Clinical Follow-Up for Medical Devices

 

WS: PM – Do more with less, faster

WS: Scheduling & proposal writing: The clinical study protocol & report

WS: Publication Planning

 

WS: Clinical Study Reports in Oncology

WS: Writing a Clinical Evaluations Plan for Medical Devices

WS: Graphical Abstracts

 

WS: Medical Writing for Biosimilars

WS: Understanding Instructions for Use of Medical Devices and Providing Support in Their Drafting

 

WS: Writing Clinical Investigation Plans for Medical Devices

WS: Statistical Analysis of Binary Data

 

WS: Writing a Clinical Study Protocol

WS: Manuscript Writing - from Good to Excellent

WS: Writing Lay Summaries of Study Results according to EU Regulations

WS: Literature Reviews for Medical Devices

WS: Introduction to Virology

 

WS: Advanced Epidemiology

WS: Statistical Testing

WS: Critical Appraisal of Medical Literature

 

WS: Subject narratives for clinical study reports

WS: Going from Pharma to Medical Devices

WS: Writing Clinical Evaluations Reports of Medical Devices

 

WS: Strategies for Improving Document Quality

WS: Medical Writing and Quality Control of Documents Entering the Public Domain: Manuscripts and Abstracts

WS: Summarizing

 

WS: Basics of Writing for Medical Devices Under the MEDDEV rev. 4 and new Medical Devices Regulations

WS: Drug Safety for Medical Writers Part 1: Adverse Events and Concomitant Medications

WS: Drug Safety for Medical Writers Part 2: Laboratory Data

WS: Basics of Epidemiology for Medical Communicators

        

WS: Medical Writing and Quality Control: CSRs

WS: Writing Global Submission Dossiers using the Common Technical Document

WS: Health Related Quality of Life

WS: From Clinical Study Report to Manuscript

WS: CORE Reference – Clarity and Openness in Reporting: E3-based

 

WS: Introduction to Writing about Efficacy

WS: Medical Writing and Observational Studies

WS: Patient Registries as a Source of Medical Information

 

WS: The Investigator’s Brochure

WS: Managing the Clinical Study Protocol Writing Process

 

and further webinars for contents of Medical and Scientific Writing

 

WS: Workshop