Seminars

The attached list of lectures shall help you to get a better understanding for the different areas of life science covered by the team. The lectures shown normally take around 5 hrs.

If wished, a combination of different ones is possible and all can be presented in  a short version.

Lectures 
   
1 EU
  Pharmaceuticals
1.0 Basics EudraLex (incl. GCP and GVP)
1.1.1 GxP as Safety- and Quality measure (GCP, GVP)
1.1.2 GCP as „Amended Version “– the GCP-Inspectors View
1.2 Market Authorization in EEA (Central, Decentral, MRA, National)
1.3 EMA/EC and EUnetHTA
1.4 Clinical Trial Regulation (EC) No 536/2014
1.5 QM: SOPs, Audit, Inspection, Fraud
1.6 Advanced Therapies Regulation (EC) No 1394/2007
1.7 Orphan Regulation (EC) No 141/2000
1.8 Paediatric Regulation (EC) No 1901/2006
   
  MD and IVD
1.20 Directives – AIMD, MDD, IVDD
1.20a MDR and MEDDEV 2.7.1 Rev.4 What`s new? Where are the dangers for industries? What happens with NBs, Gap-Analysis)
1.20b IVDR – What`s new? Where are the gaps?
1.21 MEDDEV, NB and other sources for better understanding of MD and IVD legislation
1.22 Medical Device Manufacturers – Main Standards, e.g. EN 9001, EN 13485, EN 14971
  Others
1.30 Health Systems in EU with selected examples (D, F, UK, E, NL, S)
   
2 Germany
Health Care System
2.0 Health System Germany from Bismarck to current situation
  Medicinal Products Act (D)
2.1 Medicinal Products Act –AMNOG (ECEA) to today
2.2 Medicinal Products Act – CTA
2.3 Marketing Authorization and Market Access (Reimbursement)
  Framework for Clinical Trials
2.10 CT – from idea to study report (an introduction)
2.10a CT Phase 0, I, II, III and IV (main target is Market Access)
2.11 New requirements for cost effective CT when developing new compounds (ECEA, CEA, BIA, PASS, PAES, DUS)
2.12 ICH-GCP and EU 536/2014
2.13 Protocol, Designs as an Opportunity, Adaptive Design und Risk Based Monitoring Plan
2.14 Investigator Brochure and GAP-Analysis
2.15 Study Medication, Labeling and other requirements
2.16 Project Management in CT
2.17 Data Management in CT
2.18 Visits, Risk Based Monitoring and Monitoring Plan
2.19 CTA to CA and IEC
2.20 Essential Documents
2.21 Case Report Form (pCRF & eCRF)
2.22 Patient Information
2.23 Informed Consent Form (ICF) and its tools
2.24 Drug Accountability
  Other important forms of studies
2.30 Non-Interventional Studies (NIS), Retro- and Prospective Epidemiologic Studies
2.31 Reliable sources in Health Care, Pharmaceutical Development and Medical devices for New Comers
  CT of MD, Performance Evaluation of IVD
2.50 Medical Device Act and its realization
2.50a/Current status Medical Device Act and current changes
2.51 MEDDEV 2.7.1, rev. 4 vs. rev.3 – What is going on for industries?
2.52 CT of MD – MPKPV, EN 14155-1/-2, IMDRF (GHTF) vs. GCP (ICH)
2.53 CTA MD and IVD (DIMDI-VO)
2.54 MD/IVD SOPs, Audit, Inspection, Fraud, Misbehavior
  Others
2.60 Pharmacovigilance
2.61 Pharma Economy/Health Economy