All seminars are designed as one day activity. They include the presentations in electronic form as well as further back-up material. A shortened format required, possible and can be arranged in most cases without problem. All seminars can be carried out on site or as webinar.

Please do not hesitate to request a mini-seminar, seminars on special items or on any other related wishes.

Seminar Package

1. The EEA’s RA Environment (CTR, MDR / IVDR) – Introduction to Clinical Research (CT, CE, PE) and their anticipated targets

The long professional history of each partner in the network will be available to provide tailor-made trainings – or you may just use our standard modules. Depending on your needs, we will always try to define the most recommendable content. Please don’t hesitate to contact us.

2. CTR and its key requirements (RA, EMA, EUnetHTA, EUDRALex, CTIS, Union Data Base, HMA, CTFG, other Information Sources, …)

Regulatory Pyramid Pharma

3. MDR/IVDR and its key requirements (RA, BfArM, PEI, G-BA, IQWIG, EUDAMED, MDCG, CAMD, NB, other Information Sources …)

Regulatory Pyramid Medical Devices

4. Pharma + IVD-MD = CDx are one of the most challenging projects and their realization is very special (RA, MDR, IVDR, CTR, EMA, BfArM, PEI, G-BA, IQWIG, EUDAMED, MDCG, CAMD, NB, other Information Sources …)

Regulatory Pyramids as Frame for CDx

Rx-CDx Development Model

4. The German Healthcare System: General Aspects of Clinical Trials / Clinical Evaluations / Performance Evaluations and their combination as Part of MA and Market Access

In addition to the above and below mentioned we think that it is one of the most important aspects we have to deal with – the respective Health System in which we are active. Being active in Germany w/o knowing about the importance of SGB V, the G-BA or other laws, guidelines or stakeholders, one is lost. Too many unknown and unexpected hurdles, but all of them can be included in the strategic planning and known risks eliminated or neutralized.

5. Instead of a „Safe Harbor Statement“

Our presentations: Pictures shown as examples can be found in the internet normally. All materials are freely or publicly accessible and are linked to the relevant pages as far as it make sense, they are helpful and conductive to follow-up work. All findings and assessments in the context of the seminars are based on personal experience, the current status of the discussion regarding new regulatory requirements (MDR, IVDR, CTR, etc.) and on the statements available to date. They are suggestions only and do not relieve the participants of their obligation to carefully review all their steps in the discussed area.