François Redelsperger Email & Phone Number

Copenhagen, Capital Region Of Denmark, Denmark

Copenhagen Metropolitan Area

⇒ Areas of expertise: Resuscitation, Cardiovascular, Emergency treatment, Medical device.Author/reviewer of:- Literature Reviews, Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Vigilance data review, PMS plan, PMCF plan according to MDR 2017/745,- Clinical investigation plans (CIP) for EU and US pilot studies, Clinical investigation report (CIR), electronic/paper case report form CRF, Investigator's Brochure (IB), Informed consent form (ICF) according to MDR 2017/745, ISO14155:2020, ICH-GCP, Exception from informed consent (EFIC- CRF 50.24) submissions and planning community consultation and public disclosure for EFIC trials in the US.- Design and writing of usability and clinical documentation (formative & summative usability protocol and report, usability engineering report (UER) according to ISO 62366:2015,- Regulatory templates and internal procedures/instructions.- Acting as a co-clinical trial manager for two international medical device clinical studies (US, Germany). Tasks included:- site identification/selection,- site initiation and site visits,- site training,- review of monitoring visit reports, CAPAs,- review of study data, safety data, sae/ae reporting- regulatory submissions to EC and CA in Europe, communications with sites.- planing and conduct of data monitoring safety committees.

Copenhagen, Capital Region, Denmark

Wound And Skin Care Innovation - Humlebæk, Capital Region, Denmark

⇒ Area of expertise: Wound Care, Medical device.Author of:- Literature Reviews, Clinical Evaluation Plans, Clinical Evaluation Reports according to Meddev 2.7/1 rev.4 and MDR 2017/745, Vigilance data review- Usability Validation Reports, Design and writing of usability study protocol according to ISO62366:2015.Scientific Advice:- Ensure scientific and clinical input to Clinical Investigation Plan, Case Report Form, Clinical Evaluation Report- Review and approval of documents (IFU, claiming document, Labelling document)- Participate in the development and maintenance of regulatory templates, internal procedures and instructions / review, comment and approve change requests and CAPA covering the products, - Data presentations.

Team Strategic Consultancy - Køge, Denmark

⇒ Areas of expertise: providing support to companies for the development of their regulatory strategies as a consultant on more than 15 medical device related projects including hearing aid, cardiovascular, imaging, airway, dental and monitoring devices.- Performing clinical evaluations (design of the strategy, establishment of equivalence, literature search in Medline, Cochrane, Embase databases and literature review / search and review of safety data from US and European databases / writing clinical evaluation reports according to MEDDEV 2.7/1 rev4 / GAP Analysis for CER from MEDDEV 2.7/1 rev3 to rev4), preparing post-marketing surveillance plans, including post- marketing clinical follow-up studies.- Reviewing documentation (CIP, technical documentation, i.e. risk management files, conformity assessments to standards, biological evaluations, product labelling and essential requirements checklists).- Teaching activities: "Introduction to Clinical Evaluation" (Medicoindustrien)

Vaccine Clinical Trial Unit - Glaxosmithkline Laboratory - Marly Le Roi, France

⇒ Areas of expertise: Prophylactic/therapeutic vaccines, Virology / Infectious diseases, Oncology, Immunology- National coordination of 4 international phases II / IIIb clinical studies in compliance with ICH, GCP, GSK SOP (solving the queries related to eCRF completion, writing communication plans / local summaries / ICF templates / patient questionnaires).- Coordination of 1 feasibility study (selection of investigator sites, management of confidentiality agreements).- Preparation of regulatory EC submissions for protocol amendments, review of summaries, informed consents in view of obtaining approvals in France.- Management of laboratory material, sampling and essentials documents.- Follow up of budget (International and multicentric studies).- Identification of sites issues and initiation of corrective plans based on monitoring reports to ensure data integrity, subject safety and adverse event reporting.- CRA activities: on-site monitoring visits (monitoring and close-out multiple site locations, pharmacy accountability, Investigator and Sponsor Trial Master File inventory, source data verifications, filling eCRF).

Umr 8122, Institut Gustave Roussy - Villejuif, France

⇒ Areas of expertise: Virology, Myology, Placentation, Reproductive Health"Characterization of endogenous retroviral envelop proteins during cell-cell fusion".Taking advantage of knock-out mouse models and mammalian cell cultures, I managed academic research projects related to endogenous retroviruses. Based on histological analysis and cellular assays, my work has lead to the identification of several endogenous retroviral genes and highlighted their direct contribution to cell-cell fusion during the formation of muscle tissue and placentation in mammals.

Inserm U845 - Centre De Recherche Croissance Et Signalisation - Paris, France

⇒ Area of expertise: Virology, Hepatology, Cellular Biology, Immunology, Oncology"Clinical implication of Hepatitis B in liver pathogenesis".During my PhD, using transgenic mouse models and samples of HBV infected patients, I studied the implication of HBV spliced variants and the HBSP protein in the progression of liver disease. My PhD work has demonstrated a correlation between the level of HBV splicing and the severity of the associated liver disease in patients and showed an implication of HBSP protein in liver inflammation and fibrosis.

University Paris Descartes

30 hours of tutorials in fundamental and technical Cellular biology to students at medical school

Equipe Biologie Moléculaire Du Gène Chez Les Extrêmophiles

Isolation, purification and analysis of new viruses from Hydrothermal vents.

Inserm U845, Pasteur Institute, Necker Hospital

Identification of protein-protein interactions between HBV HBSP protein and co factors.

Clinical Research Associate, Clinical Research, Clinical Trials

- ICH GCP guidelines - Methodology and Regulation of Clinical Trials - Drug development process - Medical course

Felasa C, Animal Experimentation

Phd, Virology, Molecular And Cellular Biology, Summa Cum Laude

Diplome Universitaire, Virology

Master, Molecular And Cellular Biology / Speciality Virology, Cum Laude

Speciality virology