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The «i-net Med­tech Af­ter-Work Re­gu­la­to­ry Af­fairs Cir­cle» is based on re­quests from par­ti­ci­pants of last year’s i-net RA Stra­te­gy work­shop. The in­ten­ti­on of the cir­cle is to meet up twice a year to dis­cuss given RA cases and re­la­ted ac­tua­li­ties in an open and con­struc­tive man­ner. The cir­cle is de­di­ca­ted to med­tech re­la­ted RA, we ad­dress the event to peop­le and spe­cia­lists in­vol­ved from the field.

The goal of the RA Cir­cle is to learn from peers, to ex­ch­an­ge in­for­ma­ti­on and ex­pe­ri­en­ces, to dis­cuss chal­len­ges and to re­flect stra­te­gy with experts.

Seats are li­mi­ted, your par­ti­ci­pa­ti­on to the event is on a «first come – first ser­ved» basis. We are loo­king for­ward to mee­ting you.


17:00     Welcome and Introduction, Fabian Käser, i-net




RA insights about clinical assessment given by Dr. Ulrich Hofer, Head of Regulatory Affairs & Sciences, co-founder of ISS
Discussion, hosted by Hansjörg Riedwyl, CEO, ISS AG

18:00   Networking Apéro

The par­ti­ci­pa­ti­on is free of char­ge, but you are asked to re­gis­ter your pre­sence until 22.05.2015.


A multinational MedTec enterprise is using our RA software:

After an intense evaluation phase, another multinational MedTec enterprise has decided to use REGULA™ for all its future submissions.

In the already terminated first phase, RA processes of different locations were analysed and standards were searched and defined.

The customer is seeking to harmonize and speed up RA processes globally, to improve internal communication and the exchange of resources as well as to gain a simpler interface to its DMS. All this can be achieved thanks to REGULA™.

Harald Studer will have a lecture to a new study at the ESCRS in Amsterdam this year from 05-09 October 2013. The study was done in collaboration with the Ohio State University and compares the biomechanical effects of LASIK Flap and ReLEx Smile Cap Incisions.

The ISS Team has received reinforcement:

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Dr. Michel Weber

ISS AG decided to strengthen its competence in clinical operation services by building a separate organizational unit lead by Dr. Michel Weber joining the company. His experience as a former COO of international and Swiss Clinical Research and as Head of Clinical Research Operation at Novartis adds a lot of knowledge in all services around clinical trials. Dr. Michel Weber will also be a member of the executive board.


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Sandra Item

The ISS Team is getting reinforced by Sandra Item in the areas of regulatory affairs und knowledge management.