Brigitte Patz - TRAINING ATTENDED
Selection of advanced trainings offered by commercial seminar providers; symposia and workshops offered by professional associations and public institutes in Germany:
Medical Writing
- BPI Service GmbH - Colloquium Pharmaceuticum, Frankfurt
- 2002, Medical Writing and Preparation of Clinical Documents
- 2003, Professional Production of Scientific Texts
- FORUM Institut für Management GmbH, Frankfurt
- 2010, Successful Medical Writing
- 2015, Medical Writing in Pharmacovigilance
- 2016, Do’s and Don’ts in Regulatory Writing
Literature Research and Reference Management
- German Institute of Medical Documentation and Information
(DIMDI, Deutsches Institut für Medizinische Information und Dokumentation), Cologne - 2004, Classic Search (using command language in literature search)
- 2006, Searching Literature in Medical Databases
- 2008–2011, Annual User Meetings for Information Professionals
- Trisolve Scientific, Nuremberg
- 2008, Using the Software “Reference Manager“ Effectively
- Adept Science GmbH, Frankfurt
- 2013, EndNote X7, online training
- 2015, Searching and Publishing with EndNote
Regulatory Affairs
- BPI Service GmbH - Colloquium Pharmaceuticum, Frankfurt
- 2007, Toxicology / Non-clinical Data
- FORUM Institut für Management GmbH, Frankfurt
- 2008, Common Technical Document (CTD): Clinical and non-Clinical Expert Reports
- 2014, Labelling, Patient Information Leaflet and QRD (Quality Reference Document) Template
- German Society for Regulatory Affairs (DGRA, Deutsche Gesellschaft für regulatorische Angelegenheiten),
Bonn (workshop for members) - 2012, Update in Regulatory Affairs
- Scientific and Economic Service Provider of the Federal Proprietary Medicines Manufacturers’ Association
(BAH-WIDI, Wissenschafts- und Wirtschaftsdienst des Bundesverbands der Arzneimittelhersteller e.V.), Bonn - 2011, The European Authorisation System
- 2011, Authorisation of Phytopharmaceuticals in Europe
- 2013, Homeopathic Medicinal Products in the Scientific and Regulatory Field
- 2016, Phytopharmaceuticals: Between Tradition and Innovation
- ALPHATOPICS GmbH, Kaufering
- 2016, Phytopharmaka Symposium Symposium on Phytopharmaceuticals in Bonn
Pharmacovigilance
- BPI Service GmbH - Colloquium Pharmaceuticum, Frankfurt
- 2004, Periodic Safety Update Report (PSUR)
- 2012, Intensive Training on Pharmacovigilance
- 2012, GVP (Good Pharmacovigilance Practices) Module VII, webinar
- Scientific and Economic Service Provider of the Federal Proprietary Medicines Manufacturers’ Association
(BAH-WIDI, Wissenschafts- und Wirtschaftsdienst des Bundesverbands der Arzneimittelhersteller e.V.), Bonn - 2004, Periodic Safety Update Report (PSUR)
- 2012, Risk Management Plan (RMP)
- CenTrial GmbH, Tübingen
- 2008, Pharmacovigilance in Clinical studies
- Akademie für Fortbildung Heidelberg GmbH
- 2009, Periodic Safety Update Report (PSUR)
- FORUM Institut für Management GmbH, Frankfurt
- 2013 and 2015, Periodic Safety Update Report (PSUR).
- 2015, Periodic Safety Update Report (PSUR), Periodic Benefit-risk Evaluation Report (PBRER) Format; How to Write Step-by-step
- 2015, Medical Writing in Pharmacovigilance
- German Society for Reguatory Affairs (Deutsche Gesellschaft für Regulatorische Angelegenheiten, DGRA),
Bonn (workshop for members) - 2015, Pharmacovigilance
Clinical Studies
- Federal Association of Contract Research Organisations (Bundesverband Medizinischer Auftragsinstitute, BVMA), Munich
- 2005, Clinical Studies According to Good Clinical Practice (Directive 2001/20/EC)
- BPI Service GmbH - Colloquium Pharmaceuticum, Frankfurt
- 2005, Data Management and Analyses in Clinical Studies
- German Society for Regulatory Affairs (Deutsche Gesellschaft für Regulatorische Angelegenheiten, DGRA),
Bonn (workshops for members) - 2010, Clinical Trials According to the Amended Medical Devices Law
- 2013, Clinical Trials Applications
- Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn
- 2012, Publication of Clinical Trials According to §42 b AMG (German Medicines Act)
- 2015, Clinical Trials Regulation EU 536/2014
- FORUM Institut für Management GmbH, Frankfurt
- 2009, Scientific Studies with Foods and Food Supplements
- 2014, Non-interventional Studies
