Expert Opinions

Examples

·       Benefit assessment/market access/reimbursement/supply chain (AMNOG – IGWiG/G-BA/SHI):
clinical (mortality, morbidity, and surrogate endpoints), economic, and humanistic (patient reported, QoL) outcomes. 
for example, 
cancer/immuno-oncology (breast cancer, malignant melanoma, pancreas, multiple myeloma),
CV diseases (heart failure, ACS/MI, long QT syndrome, stroke/SEE prevention, lipid disorders),
diabetes,
asthma/COPD (incl. IT devices),
Parkinson’s disease,
meningococcal disease prevention/vaccination,
RDS-CRM,
migraine and cluster headache,
botulinum toxin type A. 

·      Pharmacological-toxicological expert opinions; eg, 
heart failure, atrial fibrillation, anticoagulants, ACS/MI, fibrinolytics, cancer, asthma/COPD, diabetes, depression, sedatives, hypnotics.

·       Court expert opinions; eg, 

• Intoxications (blood, urine, saliva) 
• Letal intoxications (blood, urine) 
• Doping (blood, plasma/serum, urine) 
• Adverse effects (adverse drug reactions, patient safety) 
• Medication safety (AMTS, medication errors) 
• Off-label use 
• Quality/safety eg, eye drops 
• Counselling quality/(legal) requirements

·       Legal definitions and pharmaceutical assessment of medicines versus diet supplements, and dietary products.

·       Non-prescription medicines – OTC-use, pharmacy-only drugs and GSL; eg,  

• Ambroxol
• Analgesics
• Antiallergics
• Antimycotics
• Athlete’s foot meds
• Blood sugar test strips – (re-)imports
• Cough medicines
• Evening primrose oil capsules
• Fish oil products/ω-3 fatty acids
• Flu medicines
• Garlic preparations
• Ginkgo biloba
• Hemorrhoidal agents
• Hypnotics
• Ibuprofen
• α-Lipoic acid
• Meds for motion sickness
• Meds for sport injuries
• Rhinitis medicines
• Topical pain meds (NSAIDs, among others)
• (Multi-)Vitamins

·       New package for drug formulations; eg, suppositories.

·       Health promotion in primary health care; eg, general practice and community pharmacy. A European project.

·       Registration of traditionally approved herbal medicines.

·       Health claims for … in the intended use as a foodstuff.

·       Stroke prevention / atrial fibrillation (AF) – NOACs (non-VKA); eg, rivaroxaban, edoxaban;
new VKA.