Regulatory Science – special focus
My expertise in Regulatory Science is based on different jobs with diverse focusses.
As Regulatory Affairs Coordinator at the American Company Bristol-Myers Squibb (BMS) in Munich I took care of Maintenance and Lifecycle management of Marketing Authorisations (national, MRP, centralised) in the indications HIV, Oncologie and Pain. One focus was laying on the drafting and updating of SPCs und PLs.
2005 I have been promoted at BMS to a Scientific Advisor Regulatory Science by means of good success, taking over in this new task the regulatory responsibility for Marketing Authorisations in the indications HIV, Antiinfectives and CNS. Besides for the correspondence with the Competent Authorities and Ethic-Committies I was also responsible, as the regulatory representative in a Brand team, for the preparation of the centralised Marketing Authorisation and the launch of a new medicinal product in Germany. In 2006 I have got an Award for this task.
From 2004 until 2007 I performed my postgraduate studies „Master of Drug Regulatory Affairs“ at the Rheinische Friedrich-Wilhelms- Universität in Bonn. I did this in parallel to my job. The following subjects have been taught: Regulatory Science for Marketing Authorisations, national and international, in the areas EU, USA , JPN und RoW. In the focus were: CTD, CMC, Dossiermanagement, preclinical and clinical trials, Quality Assurance, Pharmacovigilance, as well as pharmaceutical law ( z.B. NML, AMG, CFR, relevant Guidelines) and different Marketing Authorisation Proceduresund Arten von Zulassungsverfahren (z.B. MRP, DCP, centralized procedure in der EU, NDA in the USA). My Master Thesis “Extended Role of Scientific Advice as A Consequence of The NML in The EU Including A Comparison to The Situation in The US” was assessed as “sehr gut” (A).
In December 2006 I changed jobs internally and gained experience in Drug Safety as Scientific Advisor Phamacovigilance. My task was the documentation, assessment and reporting of ADRs, mainly in the indication Oncology.
In January 2008 I took over a new challenge at the MEDA Pharma GmbH, Bad Homburg, as a Manager Drug Regulatory Affairs. In the scope of this task I was , among others, responsible for EU Marketing Authorisation Procedures (MRP, DCP), e.g. I led a project to gain approval for a Marketing Authorisation Application of a new developmental medicinal product (Indication: Allergy) based on a US-Dossier, which had to be adopted to apply to EU-requirements. During this project I have learned a lot about regulatory strategies, legal bases of Marketing Authorisation Applications and negotiations on this topic with Competent Authorities (e.g. MHRA, AGES, MEB etc.) I worked with different teams, e.g. with the marketing department (How to choose the Name of the medicinal product, brand and patent issues), and I worked with the medical department on the strategy of additional Clinical Trials and on the implementation of results from a Scientific Advice. I was the coordinator of a team with external consultants, who assisted us with the restructuring of the US data material into an EU-Dossier.
Moreover I held internal trainings for young colleagues (e.g. presenting summaries of external trainings I had attended). Besides the tasks described, the submission and processing of Variations (especially EU-Harmonisation Variations), Renewals and PSURs were part of my daily business.
Due to my different jobs and due to my MDRA-studies I have gained a good overview about Drug Regulatory Affairs, what it contains and what it means in its substance. Therefore I decided 2011 to work as a freelance consultant and offer my in-depth knowledge to interested Pharmaceutical companies. Up until now I have had contracts in Regulatory Affairs (Maintenance) and Pharmacovigliance. This year I have founded the Regulatory Science and Clinical Research GmbH. Please see my CV for further details.
Ellen Güttler
Neustraße 9
67578 Gimbsheim/Rhein
Germany
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Hintergrundfoto: (c) Rainer Sturm / pixelio.de
