Personal Details

Dr. med. Arne Erdmann

Date of Birth: 30.04.1964 in Leverkusen

Address: Zur Kohlstatt 2

D – 82211 Herrsching

Telephone: +49 / (0) 151 2405 4605

E-Mail: Arne.Erdmann@Klinfor.de

Website: Klinfor.de

Marital Status: married

Employment history:

Since 2025 Online-Practice for Hypnotherapy

2023 – 2024 Education for Hypnotherapy

11.04.2022 – 31.07.2022 Fresenius-Kabi, Switzerland

Pharmacovigilance Consultant

01.04.2021 – 30.11.2021 Immunic, Gräfelfing

Medical Reviewer

Medical review and co-ordination of finalization of a CSR in COVID-19

Head of Pharmacovigilance

Initiation of building up the pharmacovigilance department

01.04.2020 – 31.12.2020 Morphosys, Planegg

Medical Reviewer

Medical review of studies in diffuse large b-cell lymphoma

01.07.2019 – 31.12.2019 Novartis, Basel

Medical Reviewer (part-time freelance position)

Medical Review for a Phase II study in transplantation

01.01.2019 – 31.08.2019 Abbott,Hannover

● Medical Safety Expert (part-time freelance position)

Signal detection and Safety report writing for various drugs

01.08.2018 – 31.10.2021 Bayer, Berlin

● Medical Reviewer (part-time freelance position with variable FTE) Medical review of study data in ophthamology

10.07.2012 – 31.12.2018 Novartis, Basel

Medical Reviewer (fulltime freelance position)

Medical review of international studies in transplantation and juvenile arthritis

15.06.2009 – 18.05.2012 Astellas Pharma GmbH, München

Medical Advisor (in-house fulltime freelance position)

Management of international studies for Germany, Austria and Switzerland, budget responsibility and line manager for the involved study team.

Benign prostate hyperplasia, Phase III
Prostate cancer, Phase III
- Invasive fungal infection prophylaxis in high risk patients liver transplantation, Phase III
- Pre-emptive invasive fungal infection therapy in patients with peritonitis after abdominal surgery, Phase II
Clostridium difficile infection treatment in high risk immunocompromised patients, Phase III

01.10.2006 – 30.06.2009 Pharm-Olam International, München

Project Manager 01.10.2006 – 30.09.2008

Project Management including budget responsibility and line management for national and international studies, phase I and III, attending and presenting at investigator and bid defence meetings.

Lupus erythematosus, Phase III
Cat allergy, Phase I
Pneumonia, Phase III

Medical Monitor 01.10.2008 – 30.06.2009

Responsible for Medical Monitoring and Drug Safety of international studies phase II – III

NSCLC, Phase II
Rheumatoid arthritis, Phase II
Acromegaly, Phase III

01.07.2004 – 30.09.2006 UCB GmbH, Kerpen

Medical Scientific Advisor

Responsible for 12 investigator initiated studies conducted in Germany, regular contact to opinion leaders- indication was epilepsy, also giving scientific advice to investigators

03.02.2003 – 30.06.2004 MDS Pharma Services, Langenfeld

Project Manager

Project Management of international studies phase III

Onychomycosis, Phase III
Hand dermatitis, Phase III

Monitoring of national and international studies phase II and IV

CABG, Phase IV
Prostate cancer, Phase II
Renal failure, Phase IV

01.04.2002 – 30.04.2002 Viscum AG, Bergisch Gladbach

Medical Advisor

Protocol development for a phase I study

01.07.1996 – 31.03.2002 Omnicare Clinical Research, Cologne

Medical Writer 01.07.1996 – 31.12.1996

Writing of 6 integrated study reports, 1 CRF and 1 Protocol

Monitoring of clinical studies phase II and IV, initiation and recruiting phase, maintenance of regulatory files, SAE reporting, attendance of investigator meetings

Erythropoesis, Phase IV
Hypertension, Phase II
Ovarian cancer, Phase II
NSCLC, Phase II

Project Manager 01.01.1997 – 31.07.1999

Project Management of national and international studies phase III: Effectively manage of all aspects of assigned clinical trials according to the specificities of the sponsor’s contract; Control project team activities to ensure ICH-GCP guidelines and SOPs are strictly observed, including study preparations, site initiations, periodic monitoring, status and safety reporting; Regularly meet and liaise with sponsor to ensure study conduct and completion are progressing according to sponsor needs and established study timelines; Coordinate all ancillary aspects of the study, including vendor management, data management, pharmacovigilance, statistician, and medical writer

Atrial fibrillation, Phase III
Artherosclerosis, Phase III

Safety Officer 01.08.1999 – 31.03.2002

Responsible for the Drug Safety of 6 studies phase II – III

Resident:

01/1996 – 06/1996 Rheinische Landes – und Hochschulklinik Düsseldorf (Psychiatry)

10/1994 – 09/1995 Private practice Dr. Storch, Düren (Nuclear medicine)

Civilian Service:

04/1984 – 02/1985 Mobile social service, „Arbeiterwohlfahrt“, Cologne

11/1983 – 03/1984 Home for the aged in Leverkusen

Therapeutic Experience:

Cardiovascular	Gastroenterology
Gynaecology	Immunology
Infectious diseases	Musculoskeletal
Nephrology	Neurology
Oncology	Psychiatry
Transplantation	Covid 19

Education:

Dissertation:

1992 – 1998 University of Cologne, title: „Laserangioplasty of Peripheral Arteries“

(experimental work, “cum laude”)

Studies:

1985 – 1992 Human medicine (MD)

University of Cologne

Graduation: License to practice medicine

1970 – 1974 Primary school in Leverkusen

1974 – 1983 Secondary school in Leverkusen

Graduation: University-entrance diploma

Languages:

German – Mother tongue

English – Business Fluent

French – Good Knowledge

Spanish – Good knowledge

Memberships: Ärztekammer Bayern (Chamber of physicians)

Deutsche Gesellschaft für Pharmazeutische Medizin (DGPharMed)

Study Details Form:

Role on Study (e.g. CRA, CPM etc.)	Indication	No. of patients	No. of sites	Countries involved	Services involved (e.g. full service or just clinical)	Stages of study involved (e.g. set up to end, just close-out etc.)
Medical Writer	Rejection prophylaxis	80	10	Germany	Integrated clinical study report	NA
Medical Writer	Burn	10	1	Germany	Integrated clinical study report	NA
Medical Writer	Helicobacter pylori infection	300	40	Germany	CRF-Design	NA
Medical Writer	Infertility	400	50	Germany	Integrated clinical study report	NA
Medical writer	Arthrosis	80	12	Germany	Protocol development	NA
Medical writer	Allergic rhinitis	70	8	Germany	Integrated clinical study report	NA
Medical writer	Allergic conjunctivitis	70	8	Germany	Integrated clinical study report	NA
Medical writer	Morbus Wegener	90	12	Germany	Integrated clinical study report	NA
CPM/CRA	Atrial fibrillation	1200	60	Germany, Czech republic	Full service	Set-up to recruiting
CRA	Erythropoesis	120	6	Germany	Full service	Set-up to recruiting
CRA	Hypertension	110	7	Germany	Full service	Set-up to recruiting
CRA	Ovarian cancer	100	5	Germany	Full service	Set-up to recruiting
CRA	NSCLC	100	8	Germany	Full service	Set-up to recruiting
CPM	Artherosclerosis	500	35	Germany	Full service	Set-up to recruiting
Safety Officer	Pneumonia	400	60	Germany	Full service	Set-up to end
Safety Officer	Schizophrenia	120	20	Germany	Full service	Set-up to end
Safety Officer	Torticollis	240	26	Germany	Full service	Set-up to recruiting
Safety Officer	Blepharopspasm	240	28	Germany	Full service	Set-up to recruiting
Safety Officer	COPD	220	23	Germany	Full service	Set-up to recruiting
Safety Officer	Small cell lung cancer	90	7	Germany	Full service	Set-up to end
CRA	CABG	110	8	Germany	Full service	Recruiting
CRA	Prostate cancer	85	7	Germany	Full service	Recruiting
CRA	Renal failure	240	12	Germany, Austria, Switzerland	Full service	Recruiting
CPM	Onychomycosis	220	11	Germany, France	Full service	Set-up to recruiting
CPM	Hand dermatitis	260	14	Germany, Switzerland	Full service	Set-up
Medical scientific advisor	Epilepsy	500	12	Germany	Full service	Set-up to end
CPM	Lupus erythematosus	260	20	Germany, Austria, Switzerland, USA, Georgia, Russia, Ukraine, Poland	Full service	Set-up
CPM	Cat allergy	88	1	Germany	Full service	Set-up to end
Medical monitor	NSCLC	120	50	Canada, Georgia, India, Poland, Romania, Russia, Serbia, New Zealand, Australia	Full service	Set-up to recruiting
Medical monitor	Rheumatoid arthritis	120	30	Canada, Georgia, India, Poland, Romania, Russia, Serbia	Full service	Set-up to recruiting
Medical monitor	Acromegaly	140	50	Germany, Czech Republic, Poland, Hungary, Russia, USA	Full service	Set-up to recruiting
CPM / Lead CRA	Pneumonia	610	80	Spain, France, Estonia, Serbia, Georgia, South Africa, Slovakia, Hungary	Full service	Recruiting to end
Medical Advisor	Benign prostate hyperplasia	1500	20	Germany	Set-up	Set-up
Medical Advisor	Prostate Cancer	250	6	Germany, Austria, Switzerland	Set-up	Set-up
Medical Advisor	Invasive fungal infection of liver transplant patients	300 (90 in Germany)	6	Germany, Austria, Switzerland	Set-up to end	Set-up to end
Medical Advisor	Pre-emptive antifungal treatment in patients with peritonitis after surgery	360 (60 in Germany)	5	Germany, Austria, Switzerland	Set-up to end	Set-up to end
Medical advisor	Clostridium difficile infection in high risk immunocompromised patients	650 (150 planned for Germany)	6	Germany	Feasibility
Medical reviewer	Transplantation (10 studies)	5000	50	International	Medical review
Medical reviewer	Juvenile arthritis	300	10	China	Medical review

Curriculum Vitae

Personal Details

Civilian Service:

Education:

Studies: