Resources Hub
Welcome to the Asphalion Resources Repository
Asphalion
MedTech Blog
A compilation of insightful articles on MedTech Regulatory Affairs.
Asphanet Pharmacovigilance Interactive Map
Click on the countries to learn about the local safety requirements.
Glossary of Pharmaceutical
Regulatory Acronyms
Comprehensive glossary that provides clear definitions of pharmaceutical achronims.
Global Pharmaceutical
Regulatory Agencies Directory
Interactive directory of the main pharmaceutical regulatory agencies around the world.
Regulatory
Resources Library
Find here a collection of resources that can be useful in your day-to-day: Flyers, infographics, videos, webinars, whitepapers, etc.
We put at your disposal these useful and handy tools:
WEBINAR | Pre-clinical Testing Requirements under Regulation (EU) 2017/745 on Medical Devices: A Notified Body’s Perspective
Webinar recording
VIDEO | Key dates in the Regulatory Landscape for the MedTech Industry
MedTech-Week
FLYER | Advertising of medical devices
Advertising of medical devices (ES requirements)
WEBINAR | Biological Impurities: Scientific and Regulatory Aspects
Webinar recording
WEBINAR | Navigating the landscape of EU Data Disclosure Procedure
Webinar recording
MDGC Guidance on MDSW
New guidance
White paper | Clinical Testing Under EU MDR and IVDR: Ensuring Safety and Performance
MedTech- Week
FLYER | How to Navigate EU Regulations for Medical Devices with Nanomaterials
MedTech- Week
BUSINESS CASE | EU and US support for Medical Devices
MedTech Week
VIDEO | The Outsourcing Trend in Regulatory CMC Activities
CMC Week
ARTICLE | The relevance of Chemistry, Manufacturing and Controls (CMC) in drug development
CMC week
BUSINESS CASE | Preparation of an IMPD for an ATMP product
CMC week
FLYER | Driving Success Through CMC Due Diligence and GAP Analysis
CMC Week
International Recognition Procedure (IRP)
A must-watch for anyone involved in regulatory affairs or lifecycle management.
INFOGRAPHIC | Revision of the Medicines Variation Framework
FLYER | Additional National Procedures for Medical Devices (AEMPS)
Additional National Procedures for Medical Devices in the Spanish Market
