Our Life science webinars

Regulatory affairs

Relations avec les Organismes Notifiés

Dans le cadre de la mise en œuvre du Règlement (UE) 2017/745, les relations entre les organismes notifiés et les fabricants de dispositifs médicaux peuvent devenir plus complexes, ce qui peut affecter vos démarches

Product Develoment

Prime Scheme – A Tailored Development

Medtech

Clinical Validation of Software Integrating AI

Pharmacovigilance

Integrating Local PV System into Global PV System

Quality compliance

Annex 1 Changes and challenges: a concrete return of experience from the clients

Product Develoment

Acceptance of NDA/MAA with only Chinese Patients by Western Regulatory Agency

Innovation

Regulatory Operations

How to use regulatory document sources to build an IDMP data model?

Product Develoment

Scientific Advice Meeting: Ensuring successful interactions with regulatory authorities

Innovation

Navigate GenAI Complexity to create new values in regulatory affairs