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 | Mastering the Safety Management Plan in Clinical Trials: Key points
Webinar recording
PV-month | The Importance of SAE Management in Clinical Trials
PV-month | Digital Solutions for Local Activities
A Cost-Effective Solution for Literature Searches
Have a look at this infographic about a centralized and cost-effective solution for literature searches thanks to AsphaSearch
FLYER | EU Authorized Representative, UK Responsible Person and US Agent
When manufacturers of medical devices operate outside certain regulatory regions, they must appoint an official representative to ensure compliance with local laws and regulations.
PV-month | The Evolution of Veterinary Pharmacovigilance in Recent Years
FLYER | Understanding Usability: Definition and principles
By prioritizing usability, devices achieve their intended purpose while protecting patients and users.
FLYER | Risk Management ISO 14971
Risk Management for Medical Devices: Navigating ISO 14971:2019
FLYER | EU Authorized Representative, UK Responsible Person, US Agent
The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer, and provide a copy of the mandate to the competent authority, upon request.
WEBINAR | Review of hot topics in Regulatory & Safety + Outlook into 2025
Webinar recording
How to overcome a veterinary inspection
Have a look at this infographic about the processes necessary to ensure you are well-prepared for veterinary pharmacovigilance inspections.
PV-month | Detection of Safety-related information on the Internet
Safeguarding Health in the Digital Age
Have a look at this infographic about advancing Pharmacovigilance with Cutting-Edge Tools
WEBINAR | Strategies for choosing the best regulatory pathway for your project
Webinar recording
FLYER | eCTD 4.0: A Brave New World
New eCTD 4.0
WEBINAR | Signal Management Process in Veterinary PV: Practical Experience
Webinar recording
