Personal Details

Dr. Elke Schlüssel
Scientific Project and Compliance Manager

Phone: + 49 89-3187-2040
E-mail
Building/Room: Campus Neuherberg, building 3620, room 302c

Short profile

Education: Biologist (Dipl.-Biol. Univ., Dr. rer. nat. - TUM, Fraunhofer), Medical Writer (EMWA), Auditor

Experience

Basic bio-medical research, development of medicinal drug products and medical devices, for 20+ years in academic institutions and industry

Good Research Practice (GRP), Good Laboratory Practice (GLP), Good Cell Culture Practice (GCCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP) and other standards

Special interests

Innovative application methods and advanced therapy medicinal products, such as transdermal delivery, inhalation (pulmonary targeting), stem cell research (replacement, regeneration therapy)

Roles

Pre-/Clinical Research Associate, Project Manager Clinical Trials/Non-Interventional Studies, Regulatory Compliance Specialist, Quality Assurance Manager/Auditor, Medical Writer, Medical Journalist

At IDR

Scientific Project Manager since 05/2013.

Responsibilities

·         Proposal / grant writing and submission (e.g. NIH, ERC, BMBF)

·         Project management / alliance management

·         Project reporting / support of manuscript writing and press releases

·         Maintenance of authorization a/t Stem Cell Act

·         Animal trial authorizations from local authority (ROB) a/t Animal Welfare Act

·         Positive votes from local Ethics Committee (TUM) for biomedical research projects (human materials, e.g. islets and iPSC)

·         Maintenance of registry information (MausDB, AnimalTestInfo, hPSCreg)

·         Quality assurance (SOP system, training, consulting, oversight of records)

·         Data Protection Coordinator

Memberships

German Association of Specialised Journalists/Deutscher Fachjournalisten-Verband DFJV, German Association for Pharmaceutical Medicine/Deutsche Gesellschaft für Pharmazeutische Medizin DGPharMed, European Medical Writers Association EMWA, European GDP Association

Publications

1. Schlüssel, E. ; Migliorini, A. ; Bader, E. & Lickert, H.: Diabetes mellitus: Zelluläre Plastizität und Perspektiven für die regenerative Therapie. For. Med. Exz. Med. 5, 43-47 (2015)

2. Vromans L, Doyle G, Petak-Opel S, Rödiger A, Röttgermann M, Schlüssel E, Stetter E.: Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics. BMJ Open. 2013 Aug 21;3(8):e003033. doi: 10.1136/bmjopen-2013-003033. PMID: 23965932