Regulatory publishing for Europe – Make sure you know the basics

This training provides understanding of the eCTD structure, including architecture, compliance assessment, and publication tools. The course covers document compliance criteria, validation tools, and the eSubmission process, including existing portals.

December 10th, 2024

Bespoke interactive e-learning

EFPIA Code – Gain a better understanding of what these are

This training focuses on understanding the EFPIA Code rules, digital communication, and advertising limits. It covers topics such as promoting prescription-only medicine, digital communication specifics, disease awareness campaigns, and complying with local requirements in different countries.

November 28th, 2024

Bespoke interactive e-learning

Originator and Reviewer ABPI Workshop

This half-day workshop introduces originators and reviewers to the ABPI Code and how it applies to them. To help understand the practical aspects, review techniques and checklists will be discussed, rounded off with case examples and exercises. 

July 22nd, 2024

Bespoke interactive e-learning

Brazilian Regulatory Environment – an Overview on CMC and Module 3 Requirements for Synthetic Medicines

Gain a deeper understanding of the specific regulatory requirements and challenges in Brazil to ensure that your products comply with ANVISA regulations. The key learnings of this training are:

• Understand the regulatory environment in Brazil
• Understand the regulatory requirements for registering a drug in Brazil, focusing on Module 3

December 2nd, 2024

Bespoke interactive e-learning

Good Distribution Practices in the EU

A pragmatic approach to the distribution of medicines in the European community, with particular attention to the challenges faced by small and medium-sized enterprises. The key learnings of this training are: o Introduction to EU Good Distribution Practices

April 25th, 2025

Bespoke interactive e-learning

Agencies and the Code

This course is aimed at Originators, Reviewers and all agency staff and covers the responsibilities of all stakeholders in the review and approval process.

Bespoke interactive e-learning

AQP and AQP Signatories

This course covers the definitions and responsibilities of AQPs, AQP Signatories and Medical Signatories.

Bespoke interactive e-learning

Creation and Approval of Websites (Signatories)

For anyone involved with the creation, review and approval of UK company-owned websites. This course is about the creation and review of websites to ensure their content and format adhere to compliance requirements set out in the ABPI Code of Practice.

Bespoke interactive e-learning

Introduction to the ABPI Code

A short course introducing new starters to the requirements of the UK ABPI Code. Learners can test their knowledge with a validation quiz at the end.

Bespoke interactive e-learning

Mutual Recognition and Decentralised Procedures – ensure you know what is required

High-level introduction into mutual recognition and decentralized procedures. This training is designed for Pharmacist, Physicians and other functions (Regulatory Affairs, Development) better understand the European procedures of mutual and decentralized recognition. But anyone interested in the topic can register.

November 5th, 2024

Bespoke interactive e-learning

Centralised Procedure : gain a deeper understanding of what is expected

High-level introduction into centralized European procedure. This training is designed for Pharmacist, Physicians and other functions (Regulatory Affairs, Development) who want to better understand the centralized European procedure. But anyone interested in the topic can register.

October 8th, 2024

Bespoke interactive e-learning

ABPI & IPHA Codes – The differences

A short course allowing those who review and certify materials to understand the differences and requirements between the UK ABPI and Irish IPHA Codes.

Bespoke interactive e-learning

Statistical Process Control (SPC)

This extensive training on Stability Studies will provide deep insights into statistical process control. Register and learn from the knowledge of our expert Laurent Natalis.

Bespoke interactive e-learning

Creation and Approval of Websites (Originators and Reviewers)

For agency staff and anyone involved with the creation, review and approval of company-owned websites.

Bespoke interactive e-learning

Stability Studies

This extensive training on Stability Studies will provide deep insights into kinetics, basic statistical principles, clinical specifications, and detailed information about ongoing stability studies. Register and learn from the knowledge of our experts Laurent Natalis and Pierre Lebrun.

Bespoke interactive e-learning

Bayesian statistics

This extensive training on Bayesian statistics will provide deep insights into main Bayesian concepts, will illustrate Bayesian methodology, and show decision-making processes and Bayesian software.

Bespoke interactive e-learning

Statistical DoE & Modelling using JMP

This extensive training on Statistical DoE & Modelling using JMP will provide deep insights into statistics using JMP, linear models, response surface models and design of experiments. 

Bespoke interactive e-learning

Originators and Reviewers

For those involved in the copy approval of promotional and non-promotional material, this course covers all aspects of the copy approval process, from concept to certification.

Bespoke interactive e-learning

Transfer of analytical method and bioassay with applications

This training will provide deep insights into the objective of Validation and the Objective of Transfer, Regulatory expectations and guidelines in Transfer and many more topics. Register and learn from the knowledge of our expert Eric Rozet.

Bespoke interactive e-learning

Qualification and validation of bioassays

This extensive training on validation will provide deep insights into regulatory requirements, introduction in statistics, computational details, and all-in-one designs of experiments. Register and learn from the knowledge of our expert Eric Rozet.

Bespoke interactive e-learning

Final Signatories

An experiential program that improves Code knowledge and other essential signatory skills. The e-learning can be taken on its own or followed by mentoring sessions where aspiring signatories participate in a group discussion facilitated by an experienced PharmaLex signatory trainer.

Bespoke interactive e-learning

Prescribing Information Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Advanced JMP topics: JSL programming

This extensive training on advanced JMP topics will provide deep insights into the many actions you can perform with JSL. Register and learn from the knowledge of our expert Jean-François Michiels.

Bespoke interactive e-learning

Disclosure of transfers of value Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

MSLs Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Patient Organisations Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Emails Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Meetings & Hospitality Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Social Media Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Websites Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Medical Stands / Symposia Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Representatives Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

External speakers Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Advisory Boards Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Oncology Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Respiratory Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Diabetes Cases

This course includes summaries of cases published by the PMCPA.

Bespoke interactive e-learning

Pre-license activities

This course covers a wide range of pre-license activities and is useful for anyone (commercial or medical) seeking clarity on how to conduct such activities and comply with the Code.

Bespoke interactive e-learning

Field Medical

For MSLs and MSL Managers, designed to increase compliance knowledge and understanding of how the Code applies to MSL activities. Associated PMCPA case rulings are discussed throughout.

Bespoke interactive e-learning

Field Promotional

For sales reps and managers who would like to increase their knowledge of the practical application of the Code. Overview of Code requirements and illustration through discussion of actual PMCPA cases throughout.

Bespoke interactive e-learning