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In-house & bespoke training:
Regulatory Affairs
Our regulatory affairs training courses have been designed to update delegates on a wide range of regulatory topics, from updates on the latest regulations to registration procedures and strategies. We provide information on regulatory approval in key regions globally, with practical advice from our expert speaker panel.
Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book
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.
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
AI & ML in Clinical Trials: Fundamentals, Applications, and Regulatory Aspects
In-house & bespoke training
AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.
Typically presented by Zuzanna Kwade (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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 Stuart Angell (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
An Overview of EU and UK Regulatory Affairs
In-house & bespoke training
This two-day course provides an introduction to pharmaceutical regulatory affairs and the fundamentals of drug development. It is particularly valuable for those who are new to the regulatory function or work in a supporting or interactive role.
Rated by attendees to the public programme
Typically presented by Norah Lightowler (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Clinical Quality Management Systems
In-house & bespoke training
A two-day course that will ensure you comply with new regulatory requirements.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Clinical Trial Regulatory Requirements
In-house & bespoke training
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and a brief review of key FDA requirements.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
EU Pharmaceutical Regulations and 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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Delivery: collaborative classroom |
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) , Nancy Consterdine (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3
In-house & bespoke training
Optimising oversight for inspection compliance.
Rated by attendees to the public programme
Typically presented by Laura Brown (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
Mastering CTD Submissions 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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
In-house & bespoke training
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Rated by attendees to the public programme
Typically presented by Koen Cobbaert (bio) , Zuzanna Kwade (bio)
| Typical duration: 5 days | |
| Pricing from £1,875 per attendee | |
| Delivery: collaborative classroom |
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
| Typical duration: 2 days | |
| Pricing from £800 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
Orphan Drug Regulatory Masterclass: EU & US Insights
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 3 days | |
| Pricing from £1,350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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.
| Pricing from £1,350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 90-minutes days | |
| Pricing from £200 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Delivery: collaborative classroom |
The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA
In-house & bespoke training
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Rated by attendees to the public programme
Typically presented by Andrew Hewitt (bio) , David Petrick (bio)
| Typical duration: 4 days | |
| Pricing from £1,600 per attendee | |
| Delivery: collaborative classroom |
The Common Technical Document
In-house & bespoke training
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Rated by attendees to the public programme
Typically presented by Andrew Willis (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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 Nancy Consterdine (bio) , Tsz Wai Woo (bio)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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.
Rated by attendees to the public programme
Typically presented by Paul Palmer (bio)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
Understanding Toxicology: A Guide for Non-Toxicologists
In-house & bespoke training
This introductory course provides a clear and practical foundation in toxicology. It covers key principles, terminology and testing methods, helping participants confidently interpret and apply toxicological data in chemical safety and compliance contexts.
Typically presented by Laura Robinson (bio)
| Typical duration: 3 hours days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: Half-day days | |
| Pricing from £350 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 1 day | |
| Pricing from £500 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |
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)
| Typical duration: 2 days | |
| Pricing from £1,000 per attendee | |
| Delivery: collaborative classroom |