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. 
Eg, 
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

 

·       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.