Archemin

Advice & reporting for the chemical and pharmaceutical industries

Archemin Academy

The Archemin expert team wishes to share its knowledge with junior colleagues and clients. We therefore frequently organise trainings in either Dutch, French or English to which our clients are invited.

e-CTD manager training for Regulatory affairs Experts – March 20-21, 2018.

In close collaboration with Extedo, Archemin organises an “e-CTD manager” training.

EXTEDO’s eCTD manager is an off-the-shelf electronic submission management solution that satisfies your requirements for eCTD and non-eCTD submissions, whether electronic or paper.

The training will be given by an Extedo expert and will be held at the Archemin offices in Mechelen. It will be a practical and interactive session with a focus on the following key topics:

  • Elementary terminology
  • EU M1 v. 3.0.1 (same structure as 3.0.3), the upgrade of submissions from EU M1 v. 2.0
  • Creation of dossier including addition of “electronic Application Form” •Submission of lifecycle
  • Creation of hyperlinks
  • Export/import eCTD of submissions
  • MRP/DCP principles and tools
  • NeeS vs eCTD
  • IMP - Investigational Medical Products
  • Additional functionalities (document viewer, tools on document level, reviewing,…)

Target audience: Regulatory Affairs managers and Regulatory Affairs Officers who already have a sound theoretical and practical background and who wish to progress within their profession. The training is intended both as an initial and as a refresher training.

For more details and in case of questions, please contact ra [at] archemin.eu.

Pharmacovigilance

  • Basic training for Sales Representatives
  • Introduction to pharmacovigilance for employees new to the medical department
  • Developing and Managing a Compliant Pharmacovigilance System

Medical Information and Medicines Promotion

  • The do's and dont's in the promotion of medicines and health care products for Marketing Experts and Sales Representatives
  • Training the Qualified Person for Medical Information
  • Standard Operating Procedures for the Qualified Person for Medical Information

Market Access

  • Introduction to the Belgian system for Pricing and Reimbursement
  • Hospital financing
  • Non Interventional Clinical Studies in support of Market Access applications

Regulatory Affairs

  • Basic Regulatory Affairs Training
  • Interaction between Regulatory Affairs, Medical Information and Pharmacovigilance teams in small businesses
  • Quality systems for Regulatory Affairs

Quality Systems

  • ISO cerfitication
  • Good Distribution Practice for SME

Want to be kept updated on Archemin Academy initiatives / require a quote ?

Send your request to training [at] archemin.eu