Our products – AIDIFY

Post-authorisation stage of the product lifecycle

Karol — Tue, 26 May 2026 21:43:32 +0000

The course entitled “Post-authorisation stage of the product lifecycle” will explore the extensive list of responsibilities of Marketing Authorisation Holders (MAH) from the post-authorisation stage of medicinal products. Furthermore, it should be considered as a perfect introduction for the subsequent courses in the regulatory series. This course will give you a big picture of the wide array of…

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Naming of medicinal products

Karol — Tue, 26 May 2026 21:43:32 +0000

Welcome to this comprehensive course on the nuances of naming medicinal products. The pharmaceutical world is laden with challenges, and one of the crucial elements ensuring both patient safety and regulatory compliance is the accurate and clear naming of medicinal products. This course delves deep into this subject, equipping you with the knowledge and skills to navigate this complex terrain.

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Introduction to electronic submission of documentation and Electronic Application Form

Karol — Tue, 26 May 2026 21:43:32 +0000

This course is created to introduce the idea of electronic submission of documentation and electronic Application Form to the new employee of the Regulatory Affairs Department. Course is dedicated to junior specialists or specialists that start their work in pharmaceutical company and have none or limited experience in area of registration processes of the medicinal products.

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Introduction to CTIS

Karol — Tue, 26 May 2026 21:43:32 +0000

The course “Introduction to CTIS” provides a practical overview of the Clinical Trials Information System and its role in the European clinical trial regulatory framework. It is designed for professionals involved in clinical trial submissions, regulatory operations, clinical operations, project management, and related functions who need to understand how clinical trials are submitted, assessed…

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Introduction to the Marketing Authorisation application form and the basis for the eAF – Electronic Application Form

Karol — Tue, 26 May 2026 21:43:31 +0000

This course introduces the Marketing Authorisation (MA) application form and the Electronic Application Form (eAF) used in pharmaceutical regulatory submissions. It provides a practical overview of the purpose and structure of MA applications within the European regulatory framework. Participants will learn about the different types of MA applications, the key legal acts and guidelines applicable…

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Legal Regulations for the Transport of Biological Materials and a Detailed Overview of IATA Rules and Requirements in the Contex

Karol — Tue, 26 May 2026 21:43:24 +0000

This course provides a practical introduction to the legal and operational requirements for transporting biological materials in clinical research. Participants will learn the key national, EU, and international regulations, including IATA and ADR, that govern safe and compliant transport. The course explains how to classify biological materials correctly, assess transport-related risks…

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Effective collaboration between the Study Coordinator and the Clinical Research Monitor – Practical aspects of Monitoring Visits

Karol — Thu, 31 Jul 2025 16:02:40 +0000

This course explores the key elements of effective collaboration between clinical trial coordinators and monitors. Focusing on the practical aspects of monitoring visits from the perspective of the clinical trial site, participants will gain insights into optimizing communication, preparing for visits, and addressing common challenges. It is intended for clinical trial site staff—particularly…

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Moving from hype to reality: how AI can really help tackle pharma challenges

Karol — Wed, 28 May 2025 19:56:41 +0000

Unique webinar (recording) co-organized by AIDIFY and Miquido, focusing on the transformative role of AI in the pharmaceutical industry. This webinar will explore how artificial intelligence is moving from hype to practical solutions, helping pharma professionals optimize processes and innovate faster. Miquido is a company employing over 200 IT enthusiasts who achieve their clients’…

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Key updates on GVP Module XVI Risk minimisation measures (Rev 3) and Module XVI Addendum II

Karol — Wed, 28 May 2025 19:56:41 +0000

Stay up to date with the latest changes in pharmacovigilance guidance. This course provides a focused overview of key updates introduced in GVP Module XVI (Rev 3) and Addendum II, covering the latest regulatory expectations, best practices in designing and implementing risk minimisation measures, and implications for MAHs. Ideal for pharmacovigilance professionals looking to ensure compliance and…

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Clinical Trial First Step

Karol — Thu, 22 May 2025 04:32:32 +0000

JOB-SPECIFIC PROGRAMS The AIDIFY Clinical Trial First Step Program is a competency-based program crafted in line with the AIDIFY Clinical Trials Competency Framework and developed by industry experts, equips you with the necessary knowledge and skills needed to take the first steps in Clinical Trials. This program ensures you’re well-versed in functional knowledge and skills essential for…

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