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23/10/2025
Sponsored Webinar-Keeping submission timelines on track
FREE SPONSORED WEBINAR - For Regulatory Affairs professionals, every day matters. Missed review deadlines can mean delayed agency submissions, postponed trial starts, and lost competitive advantage. Yet many teams are still relying on SharePoint folders, email chains, and manual audit trails to manage critical submission documents. Join Ideagen to learn how companies and a leading antibody-based biotech have cut review cycles by up to 65%
Online
SPWIDEA25
28/10/2025
Essentials of European Pharmaceutical Regulatory Affairs
This course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.
London
United Kingdom
BAS1025
28/10/2025
Essentials of European Pharmaceutical Regulatory Affairs
This course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.
Online
BAS1025ON
28/10/2025
Sponsored Webinar-Evolution of Structured Data Submissions
FREE SPONSORED WEBINAR - The webinar covers essential terminology and concepts related to eCTD version 4.0, including key terms such as CoU (Context of Use), CoG (Context of Group), CV (Controlled Vocabulary), KW (Keywords), FWC (Forward Compatibility), and lifecycle operators, which are crucial for understanding and working with this updated electronic submission standard.
Online
SPWBEXT25
30/10/2025
CRED Optimising Regulatory Strategies for Orphan Drugs
There are regulatory processes and procedures to expedite approval and access, and to help support the development of medicines for the treatment of rare diseases. This course will provide key information about those regulatory processes and first-hand insights on how to get the best out of them.
Online
OD25O
04/11/2025
Overview of EU and UK Pharmaceutical Regulatory Affairs
This course covers all aspects of the product development process, and provides a sound overview of EU and UK legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.
London
United Kingdom
IC0112025
04/11/2025
Overview of EU and UK Pharmaceutical Regulatory Affairs
This course covers all aspects of the product development process, and provides a sound overview of EU and UK legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.
Online
IC21125O
04/11/2025
Health Economics (HTA) From a Regulatory Perspective
Health economics and Health Technology Assessment (HTA) during the development of a new medicine are becoming increasingly important. If a medicine is to reach the patient after regulatory approval, it must undergo health economic evaluation, a basis for pricing and decisions on reimbursement. This takes place at the national level in the different EU countries. Hear from TLV and Industry about the new EU HTA Regulation (EU) 2021/2282 (HTAR) that applies from January 2025 for certain medicines, about Joint Clinical Assessment (JCA) and about HTA strategy during drug development.
Sweden
SWENOV25
10/11/2025
Leadership and Strategic Management in Regulatory Affairs
This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation. The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This Masterclass is also Module 10 of the MSc.
London
United Kingdom
MSCM1025
10/11/2025
Leadership and Strategic Management in Regulatory Affairs
This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation. The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment.
Online
MSCM1025O
12/11/2025
Real-World Evidence in Health Technology Development
TOPRA in Scotland's final meeting of 2025 to be held at the ACD Centre. Join us, and our expert speakers, as we discuss the role of real-world (RWE) evidence in health technology development. RWE continues to gain prominence as a tool in health technology development with developers and regulators both looking to leverage the insights it can offer to support alternative pathways to market - whether it is through external control arms or post-launch evidence generation - there's a lot to be aware of. Despite this, the regulatory considerations around RWE are often misunderstood. Join us and our expert speakers as we look to remove some of these misunderstandings with our expert speakers.
Edinburgh
United Kingdom
SCONOV25
13/11/2025
How publishing is changing with eCTD 4.0
The Regulatory Operations (RegOps) SPIN Steering Group is pleased to present “How publishing is changing with eCTD 4.0”. This session has been designed to explore the key changes introduced by the Electronic Common Technical Document (eCTD) 4.0 and provides practical implementation examples, supported by real-world regulatory submission experience.
Online
REGOPNOV25
20/11/2025
Sponsored Webinar-Cell & Gene Therapies-key considerations
FREE SPONSORED WEBINAR - This session will focus on the obstacles faced when navigating regulations worldwide. It aims to evaluate market dynamics and emerging trends, how regulatory authorities are providing guidance, fostering collaborations, and establishing dedicated review pathways to facilitate development, and what changes to regulations can be expected in the European Union. As a bonus, we will also take a closer look at how to realize the immense potential of gene editing within the regulatory landscape.
Online
SPWBCLAR25
25/11/2025
SponsoredWebinar-Product Information prep with QRD Templates
FREE SPONSORED WEBINAR - This webinar will explore the QRD templates and provide practical guidance on how to use them while preparing product information. .
Online
SWBILL2025
26/11/2025
Essentials of European Medical Device Regulatory Affairs
This course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment.
London
United Kingdom
MDB1125
26/11/2025
Essentials of European Medical Device Regulatory Affairs
This course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment.
Online
MDB1125O
27/11/2025
TOPRA Awards for Excellence 2025 - Finalist Registration
Congratulations on being a Finalist! Join us at Plaisterers' Hall on 27 November 2025 at the Awards for Regulatory Excellence to celebrate the achievements of individuals, teams and organisations in the regulatory affairs community.
London
United Kingdom
AWARDNOM25
27/11/2025
The Awards for Regulatory Excellence 2025
Join us at Plaisterers' Hall, London on 27 November for the Awards for Regulatory Excellence to celebrate the achievements of individuals, teams and organisations in the regulatory affairs community.
London
United Kingdom
AWARDS2025
02/12/2025
Regulation of Electrical, Electronic and Software Devices
This Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impaally debate the commercial implications and the impact of the regulations on product stakeholders.
London
United Kingdom
MDM202025
02/12/2025
Regulation of Electrical, Electronic and Software Devices
This Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impact of the regulations on product stakeholders. This Masterclass is also Module 20 of the MSc.
MSCM2025O
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