Dr Hans-Joachim Kremer

Because of my long-standing experience with clinical issues in submission of drug files to authorities, I may also provide valuable advice regarding clinical development plans, principles of clinical trial protocols, analysis and reporting plans, SOPs, reporting of adverse drug reactions, claims in the SPC, responses to deficiency letters, as well as publications.

I have been working with drugs since 1980, in R&D since 1983, in clinical R&D since 1988, as medical writer since 1995.

Expertise:
My areas of expertise:

Indications: Asthma, congestive heart failure, coronary heart disease, COS/ART, dementia, dermatitis, diabetes, epilepsy, hyperlipidaemia, hypertension, immunosuppression, mania, neurology, neuropathy, pain, psychiatry, retinopathy, urticaria.

Drugs: ACE inhibitor, antiasthmatic, antiepileptic, antihistaminic, antioxidants, betablocker, betasympatholytic, cardiac glycoside, diuretic, glucocorticosteroids, HmGCoA reductase inhibitor, immunosuppressant, insulin, LHRH antagonist, neuroleptic, opioid, oral antidiabetic

Route of administration: aerosol inhaler, eye drops, IV injection, nasal spray, ointments, orally administered drugs of all formulations, powder inhaler, SC injections
Regulatory authorities: BfArM (D), EMEA (EU), FDA (USA), MCA (UK)

Documents: case report forms, clinical overviews / clinical expert reports, clinical study reports, full and abbreviated, clinical study protocols, clinical summaries, IND annual reports, investigator brochures, periodic safety update reports (PSUR), publications

Other Information:
As hands-on writer, I have substantial knowledge of the dos'n'donts of the word-processing software. Hence, I am providing ad-hoc troubleshooting for Microsoft Office software files.