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, hypertension, atrial fibrillation, anticoagulants, ACS/MI, 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 

    Miscellaneous: 
  • New package for drug formulations; eg, suppositories. 
  • Health promotion in primary health care; eg, general practice and community pharmacy. 
  • Registration of traditionally approved herbal medicines. 
  • Health claims for … in the intended use as a foodstuff. 
  • Stroke prevention/atrial fibrillation – DOACs (non-VKA); eg, apixaban, edoxaban; new VKA. 
  • Heart failure; eg, sacubitril/valsartan, medication safety/management, DDI, adherence, hyperkalemia, iron