In-house & bespoke training:
Regulatory Affairs

A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products

In-house & bespoke training

Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU.

Typically presented by Craig Evans (bio) , Dave Parry (bio)

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A Practical Approach to Veterinary Vaccine Development and Registration in the EU

In-house & bespoke training

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Rated by attendees to the public programme

Typically presented by Mel Munro (bio)

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A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

In-house & bespoke training

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

Rated by attendees to the public programme

Typically presented by Theresa Jeary (bio)
and 3 more leading experts

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Advanced Regulatory Affairs for Medical Devices

In-house & bespoke training

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Rated by attendees to the public programme

Typically presented by Steve Curran (bio) , Theresa Jeary (bio)

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An Essential Overview of Medical Information

In-house & bespoke training

In this one-day course, understand everything from the role of medical information to the guidelines for medical information and advertising.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

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An Essential Overview of the Medical Device Industry

In-house & bespoke training

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Rated by attendees to the public programme

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An Essential Overview of the Pharmaceutical and Biotech Industries

In-house & bespoke training

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

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An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

In-house & bespoke training

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

Rated by attendees to the public programme

Typically presented by Annette Callaghan (bio)

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An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

In-house & bespoke training

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

Rated by attendees to the public programme

Typically presented by Greg Thay (bio)

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An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

In-house & bespoke training

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

Typically presented by Annette Callaghan (bio)

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An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

In-house & bespoke training

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

Rated by attendees to the public programme

Typically presented by Linda Garrod (bio)

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An introduction to Risk Management ISO 14971:2019

In-house & bespoke training

Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.

Typically presented by Linda Garrod (bio)

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An Introduction to the Medical Device Regulation

In-house & bespoke training

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Rated by attendees to the public programme

Typically presented by Steve Curran (bio) , Theresa Jeary (bio)

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Animal Feed and Feed Additive Registration in China and Thailand

In-house & bespoke training

Learn how to navigate the regulatory system for animal feed and feed additives in two emerging markets.

Typically presented by Bi Jun (bio) , Anongrut (Mai) Surarutrungsri (bio) , Yang Zheng (bio)

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Antimicrobial Resistance (AMR) and 'One Health': Current Challenges, Regulatory Frontiers and Future Solutions

In-house & bespoke training

This course will allow participants to explore the regulatory landscapes governing AMR, discover innovative solutions and understand the challenges AMR poses across different sectors.

Typically presented by Linda Oyama (bio)

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Best Practice for Writing Effective SOPs

In-house & bespoke training

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

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Biological Evaluation of Medical Devices

In-house & bespoke training

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

Rated by attendees to the public programme

Typically presented by Annette Callaghan (bio)

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CAPA (Corrective and Preventative Action)

In-house & bespoke training

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

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Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

In-house & bespoke training

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

Rated by attendees to the public programme

Typically presented by Andrew Willis (bio)

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Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

In-house & bespoke training

Master the complexities of software classification under the Medical Device Regulations (MDR), ensuring compliance and clarity with expert insights into Medical Device Coordinators Group (MDCG) guidelines. Regulatory frameworks will be discussed and practical case studies will be included (to aid the learning process).

Typically presented by Koen Cobbaert (bio)

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Cleanroom Requirements for Medical Device Manufacturers

In-house & bespoke training

This course introduces key regulatory requirements for manufacturing sterile or clean medical devices in controlled environments. It covers standards for ensuring compliance, including environmental controls and third-party assessments.

Typically presented by Annette Callaghan (bio)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

In-house & bespoke training

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD).

Rated by attendees to the public programme

Typically presented by John Price (bio)

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Cyber Security for Medical Devices

In-house & bespoke training

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

Rated by attendees to the public programme

Typically presented by Ben Kokx (bio)

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Data Innovation for AI-enabled Medical Devices

In-house & bespoke training

This course provides an in-depth understanding of data governance for AI-enabled medical devices, focusing on European regulations like the AI Act and GDPR, ensuring compliance while fostering innovation in high-risk AI systems.

Typically presented by Koen Cobbaert (bio)

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Deep Dive into the IVDR Annex XIII

In-house & bespoke training

Explore IVDR Annex XIII in-depth, covering Performance Evaluation, Performance Studies, and Post-market Performance. Learn what information is required, where to put it, and when, with a detailed review of nine essential documents.

Typically presented by Jane Leadsham (bio)

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Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

In-house & bespoke training

Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.

Typically presented by Koen Cobbaert (bio)

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EU Pharmaceutical Regulations & Strategy

In-house & bespoke training

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation will be discussed in the relevant sections and impact on strategic considerations for obtaining and maintaining marketing authorisations Procedures for obtaining marketing authorisations in in the UK will be discussed.

Rated by attendees to the public programme

Typically presented by Norah Lightowler (bio)

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EU Proposed Pharmaceutical Legislation Changes

In-house & bespoke training

This course will provide an up-to-date overview of current European pharmaceutical legislation and the regulatory impact of the proposed changes.

Typically presented by Norah Lightowler (bio)

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FDA Approval Process for Medical Devices

In-house & bespoke training

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Rated by attendees to the public programme

Typically presented by Jonathan Hughes (bio)

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Global Market Access for Medical Device Software

In-house & bespoke training

Navigate global market access for medical device software with insights on international regulations, reimbursement strategies, and Health Technology Assessment (HTA) to improve your product’s chances of commercial success

Typically presented by Catarina Carrao (bio)

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Human Factors - The Increasing Importance of Instructions for Use

In-house & bespoke training

This free webinar will focus on the often overlooked but increasingly important area of instructions for use for medical products.

Rated by attendees to the public programme

Typically presented by Greg Thay (bio)

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Human Factors and Usability Engineering in the Development of Drug Delivery Products

In-house & bespoke training

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Rated by attendees to the public programme

Typically presented by Richard Featherstone (bio)

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ICH Q9(R1) Quality Risk Management (QRM)

In-house & bespoke training

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

Typically presented by Bruce Davis (bio)

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Innovate: The MedTech Series – The 2024 EU AI Act

In-house & bespoke training

This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.

Typically presented by Cheryl Barton (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR)

In-house & bespoke training

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Rated by attendees to the public programme

Typically presented by Stuart Angell (bio)

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Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)

In-house & bespoke training

Understand the essentials of performance evaluation under the In Vitro Diagnostic Regulation (2017/746) in this comprehensive seminar. Essential for regulatory compliance and business success.

Typically presented by Jane Leadsham (bio)

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Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

In-house & bespoke training

Learn the critical regulatory requirements and best practices for obtaining market authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.

Typically presented by Koen Cobbaert (bio)

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Masterclass: Market Authorisation of AI-enabled Medical Devices

In-house & bespoke training

This course provides essential guidance on navigating regulatory requirements and securing market authorisation for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.

Rated by attendees to the public programme

Typically presented by Koen Cobbaert (bio)

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Medical Device Regulation in the Eurasian Union, Russia and the CIS

In-house & bespoke training

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Rated by attendees to the public programme

Typically presented by Anna Harrington-Morozova (bio)

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Medical Device Regulations in Asia-Pacific Markets

In-house & bespoke training

As the Asia-Pacific market grows, new regulations emerge. Gain expert insights to navigate compliance and maximise opportunities.

Typically presented by Jack Wong (bio)

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Medical Device Regulations in the Middle East and North Africa

In-house & bespoke training

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen.

Rated by attendees to the public programme

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

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Medical Device Single Audit Programme (MDSAP)

In-house & bespoke training

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

Rated by attendees to the public programme

Typically presented by Stuart Angell (bio)

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Navigating China’s API Regulations: An Essential Guide to DMF Registration

In-house & bespoke training

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

Typically presented by Raymond Ng (bio) , Helen Ye (bio)

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Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

In-house & bespoke training

Gain practical guidance on EU and FDA regulations for drug/device combination products, along with solutions to current challenges, in this comprehensive course.

Rated by attendees to the public programme

Typically presented by Tina Amini (bio)
and 3 more leading experts

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Navigating Regulatory Compliance Whilst Developing and Distributing Polymerase Chain Reaction (PCR)-Based IVD Tests

In-house & bespoke training

In this three-hour course, learn from an expert about developing and distributing PCR-based IVD tests, as well as exploring the latest regulatory requirements.

Typically presented by Dmitriy Kosarikov (bio)

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Non-Conformance and Corrective Action for Medical Device Manufacturers

In-house & bespoke training

The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

Rated by attendees to the public programme

Typically presented by Annette Callaghan (bio)

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Pharmaceutical Regulatory Affairs in Africa

In-house & bespoke training

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Rated by attendees to the public programme

Typically presented by Salma Ismail (bio) , Makram Nehme (bio)

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Pharmaceutical Regulatory Affairs in Asia

In-house & bespoke training

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Rated by attendees to the public programme

Typically presented by Alan Chalmers (bio) , Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in China

In-house & bespoke training

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Rated by attendees to the public programme

Typically presented by Alan Chalmers (bio) , Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

In-house & bespoke training

This interactive course will discuss the regulatory requirements for human pharmaceuticals within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Rated by attendees to the public programme

Typically presented by Anna Harrington-Morozova (bio)

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Pharmaceutical Regulatory Affairs in the Middle East

In-house & bespoke training

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Rated by attendees to the public programme

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Pharmaceutical Regulatory Affairs in the Middle East and North Africa

In-house & bespoke training

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE, Yemen, Tunisia, Morocco and Algeria.

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

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Post-Market Surveillance - Practical Application for Medical Devices and IVDs

In-house & bespoke training

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

Rated by attendees to the public programme

Typically presented by Anne Jury (bio) , Karen Pearson (bio)

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Registration of Veterinary Pharmaceuticals in China

In-house & bespoke training

Learn how to navigate the regulatory system of veterinary pharmaceuticals in China.

Typically presented by Bi Jun (bio)

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Regulatory Affairs for Support Staff

In-house & bespoke training

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Rated by attendees to the public programme

Typically presented by Norah Lightowler (bio)

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Regulatory Compliance and Safety Standards for Aesthetic Devices

In-house & bespoke training

Navigate regulatory complexities and device classifications in the aesthetic medical device industry.

Typically presented by Catarina Carrao (bio)

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Regulatory Strategies for Orphan Drugs

In-house & bespoke training

This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Rated by attendees to the public programme

Typically presented by Shaun Stapleton (bio)

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Sterilization of Medical Devices

In-house & bespoke training

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

Rated by attendees to the public programme

Typically presented by Annette Callaghan (bio)

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The Common Technical Document (CTD) Submission in the MENA Region

In-house & bespoke training

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

Rated by attendees to the public programme

Typically presented by Mohammad Fat'hy Elnadi (bio)

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The FDA Drug Approval Process

In-house & bespoke training

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Rated by attendees to the public programme

Typically presented by Andrew Willis (bio)

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The Regulatory Requirements on Nitrosamines in the Pharmaceutical Industry

In-house & bespoke training

In this webinar, we will discuss the major requirements and strategies for nitrosamines, a hot topic that is on the forefront of many company's minds.

Rated by attendees to the public programme

Typically presented by Jason Brown (bio)

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The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

In-house & bespoke training

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

Rated by attendees to the public programme

Typically presented by Stuart Angell (bio)

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UK Conformity Assessed (UKCA) Marking for Medical Devices

In-house & bespoke training

This course provides UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK.

Rated by attendees to the public programme

Typically presented by Tina Amini (bio)

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Understanding Active Pharmaceutical Ingredients (APIs)

In-house & bespoke training

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

Typically presented by Farah Nadeem (bio) , Paul Palmer (bio)

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Understanding Computer System Validation (CSV)

In-house & bespoke training

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

Rated by attendees to the public programme

Typically presented by Paul Palmer (bio)

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Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

In-house & bespoke training

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

Rated by attendees to the public programme

Typically presented by Annette Callaghan (bio)

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US FDA - Understanding Key Factors When Working with the FDA

In-house & bespoke training

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

Rated by attendees to the public programme

Typically presented by Andrew Willis (bio)

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Variations to Marketing Authorisations

In-house & bespoke training

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Rated by attendees to the public programme

Typically presented by Andrew Willis (bio)

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Veterinary Pharmaceutical Submissions in the EU

In-house & bespoke training

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.

Rated by attendees to the public programme

Typically presented by Andrew Hewitt (bio) , Dave Parry (bio)

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