Scheduled In-house

Regulatory Affairs Training Courses

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.

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  • Next: 4 Jun 2024 Live online
  • Also: 5 Dec 2024 Live online

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

New for 2024

Live online

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.

  • 3 CPD hours High impact
  • Presented by Annette Callaghan
  • Next: 4-7 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Advanced Regulatory Affairs for Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • and Theresa Jeary
  • Next: 21 Jun 2024 Live online
  • Also: 16 Oct 2024 Live online
  • Also: 27 Feb 2025 Live online

Animal Feed and Feed Additive Registration in China and Thailand

New for 2024

Live online

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

  • 2.5 CPD hours High impact
  • Presented by Anongrut (Mai) Surarutrungsri
  • and Bi Jun
  • Next: 17-20 Jun 2024 Classroom

The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA

Summer school

Classroom

This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

  • 24 CPD hours Intensive
  • Presented by Andrew Hewitt
  • and David Petrick
  • Next: 23 Apr 2024 Live online
  • Also: 18 Jul 2024 Live online
  • Also: 12 Dec 2024 Live online

Best Practice for Writing Effective SOPs

Live online

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 15-16 Jul 2024 Live online
  • Also: 27-28 Nov 2024 Live online
  • Also: 27-28 Mar 2025 Live online

Best Practices for Supplier Qualification in Life Science

New for 2024

Live online

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

  • 12 CPD hours
  • Presented by Mustafa Edik
  • Next: 16-17 Sep 2024 Classroom

Biological Evaluation of Medical Devices

Classroom

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

  • 12 CPD hours Focused
  • Next: 22 Apr 2024 Live online
  • Also: 19 Jul 2024 Live online
  • Also: 13 Dec 2024 Live online

CAPA (Corrective and Preventative Action)

Live online

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.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 27-28 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

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

Live online

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.

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 19-20 Jun 2024 Live online
  • Also: 2-3 Oct 2024 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online

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)

  • 6 CPD hours Focused
  • Presented by Dr John Price
  • Next: 10 Jul 2024 Live online
  • Also: 28 Nov 2024 Live online

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

New for 2024

Live online

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.

  • 6 CPD hours
  • Presented by Mohammad Fat'hy Elnadi
  • Next: 4-5 Jul 2024 Classroom
  • Also: 15-16 Oct 2024 Live online

Cyber Security for Medical Devices

Live online, Classroom

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.

  • 12 CPD hours Focused
  • Presented by Ben Kokx
  • Next: 11 Jul 2024 Live online
  • Also: 29 Nov 2024 Live online

An Essential Overview of Medical Information

Updated for 2024

Live online

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 8-9 Jul 2024 Live online
  • Also: 8 Nov 2024 Live online

An Essential Overview of the Medical Device Industry

Live online

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.

  • 6 CPD hours Focused
  • Presented by Dr David Jefferys
  • and Theresa Jeary
  • Next: 10 May 2024 Live online
  • Also: 13 Sep 2024 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 10-11 Jun 2024 Live online
  • Also: 14-15 Oct 2024 Live online

EU Pharmaceutical Regulations & Strategy

Live online

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 and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 22 May 2024 Live online
  • Also: 18 Sep 2024 Live online

EU Proposed Pharmaceutical Legislation Changes

New for 2024

Live online

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation. This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

  • 3 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 19-20 Jun 2024 Live online
  • Also: 10-11 Sep 2024 Classroom
  • Also: 2-3 Dec 2024 Live online

FDA Approval Process for Medical Devices

Live online, Classroom

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.

  • 12 CPD hours Focused
  • Presented by Dr Jonathan Hughes
  • Next: 12-13 Jun 2024 Live online
  • Also: 2-3 Dec 2024 Live online

The FDA Drug Approval Process

Live online

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 10-14 Jun 2024 Live online

Global Pharmaceutical Regulatory Affairs Summer School

Summer school

Live online

Unlock the world of pharmaceutical regulatory excellence with our Global Pharmaceutical Regulatory Affairs training – an intensive journey through the diverse regions, offering practical insights, expert guidance, and strategic mastery for professionals seeking to navigate and succeed in the dynamic global regulatory landscape.

  • 84 CPD hours
  • Presented by Dr Alan Chalmers
  • + 8 more
  • Next: 5-6 Jun 2024 Classroom
  • Also: 17-20 Sep 2024 Live online
  • Also: 5-6 Dec 2024 Live online

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

Live online, Classroom

Applying HF and usability to comply with the MDR. 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.

  • 12 CPD hours Focused
  • Presented by Richard Featherstone
  • Next: 1 May 2024 Live online
  • Also: 25 Sep 2024 Live online

ICH Q9(R1) Quality Risk Management (QRM)

New for 2024

Live online

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.

  • Presented by Bruce Davis
  • Next: 11 Nov 2024 Live online

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

New for 2024

Live online

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.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 10 Jul 2024 Classroom
  • Also: 23 Oct 2024 Live online

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

New for 2024

Live online, Classroom

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

  • Presented by Greg Thay
  • Next: 21 May 2024 Live online
  • Also: 18 Nov 2024 Live online

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

New for 2024

Live online

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.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 4 Jul 2024 Live online
  • Also: 20 Nov 2024 Live online

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

New for 2024

Live online

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.

  • 6 CPD hours Focused
  • Presented by Stuart Angell
  • Next: 24-25 Jul 2024 Live online
  • Also: 5-8 Nov 2024 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online

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.

  • 12 CPD hours Focused
  • Presented by Stuart Angell
  • Next: 15-17 May 2024 Live online
  • Also: 31 Jul-2 Aug 2024 Live online
  • Also: 4-6 Nov 2024 Live online

An Introduction to the Medical Device Regulation

Live online

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.

  • 18 CPD hours Focused
  • Presented by Janette Benaddi
  • + 2 more
  • Next: 5 Nov 2024 Live online

Managing Competence within the Medical Device Industry

New for 2024

Live online

This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.

  • 1.5 CPD hours
  • Presented by Anne Jury
  • Next: 2-3 Jul 2024 Live online
  • Also: 9-10 Dec 2024 Live online

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

Live online

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.

  • 12 CPD hours Focused
  • Presented by Anna Harrington-Morozova
  • Next: 11-12 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Medical Device Regulations in the Middle East and North Africa

Live online

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

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 10-14 Jun 2024 Live online
  • Also: 2-6 Dec 2024 Live online

The Medical Device School - From Concept to CE Marking

Summer school

Live online

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours Intensive
  • Presented by Adrian Keene
  • + 7 more
  • Next: 4-5 Jul 2024 Live online
  • Also: 28-29 Nov 2024 Live online

Medical Device Single Audit Programme (MDSAP)

Live online

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.

  • 12 CPD hours Focused
  • Presented by Stuart Angell
  • Next: 22-25 Jul 2024 Live online
  • Also: 9-12 Dec 2024 Live online

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 24 CPD hours Focused
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
  • Next: 19 Jun 2024 Live online
  • Also: 12 Dec 2024 Live online

Non-Conformance and Corrective Action for Medical Device Manufacturers

New for 2024

Live online

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.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan
  • Next: 17-18 Jun 2024 Live online
  • Also: 19-22 Nov 2024 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online

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

  • 12 CPD hours Focused
  • Presented by Makram Nehme
  • and Salma Ismail
  • Next: 12-14 Jun 2024 Live online
  • Also: 9-11 Oct 2024 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online

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

  • 18 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer
  • Next: 29-30 Apr 2024 Live online
  • Also: 2-3 Jul 2024 Live online
  • Also: 10-11 Dec 2024 Live online

Pharmaceutical Regulatory Affairs in China

Live online

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

  • 12 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer
  • Next: 19 Jun 2024 Live online
  • Also: 22 Oct 2024 Live online
  • Also: 25 Feb 2025 Live online

Pharmaceutical Regulatory Affairs in Latin America

New for 2024

Live online

This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

  • 6 CPD hours
  • Presented by Belkys Ruiz
  • Next: 24-25 Jun 2024 Live online
  • Also: 3-4 Oct 2024 Live online

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online

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

  • 12 CPD hours Focused
  • Presented by Anna Harrington-Morozova
  • Next: 22-23 Apr 2024 Live online
  • Also: 26-27 Jun 2024 Live online
  • Also: 9-10 Dec 2024 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online

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

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 6 Jun 2024 Live online
  • Also: 10 Oct 2024 Live online

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

New for 2024

Live online

Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system. This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.

  • 6 CPD hours
  • Presented by Anne Jury
  • and Karen Pearson
  • Next: 5 Nov 2024 Live online

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

New for 2024

Live online

Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU. Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.

  • 6 CPD hours Focused
  • Presented by Craig Evans
  • and Dave Parry
  • Next: 8-9 Jul 2024 Live online
  • Also: 11-12 Nov 2024 Classroom

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

Classroom, Live online

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.

  • 12 CPD hours Focused
  • Presented by Dr Mel Munro
  • Next: 21 Jun 2024 Live online
  • Also: 16 Oct 2024 Live online
  • Also: 27 Feb 2025 Live online

Registration of Veterinary Pharmaceuticals in China

New for 2024

Live online

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

  • 1.5 CPD hours
  • Presented by Bi Jun
  • Next: 24-25 Sep 2024 Live online

Regulatory Affairs for Support Staff

Live online

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.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 24 Jun 2024 Live online
  • Also: 8 Oct 2024 Live online

Regulatory Strategies for Orphan Drugs

Live online

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

  • 6 CPD hours Focused
  • Presented by Shaun Stapleton
  • Next: 22 Oct 2024 Live online

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

Updated for 2024

Live online

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.

  • 6 CPD hours Focused
  • Presented by Sue Spencer
  • + 4 more
  • Next: 7 Jun 2024 Live online
  • Also: 8 Oct 2024 Live online

Risk Management for Pharma and Biopharma Professionals

Live online

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown
  • Next: 21 May 2024 Live online
  • Also: 24 Sep 2024 Live online

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

Live online

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.

  • 6 CPD hours
  • Presented by Stuart Angell
  • Next: 6-7 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Sterilization of Medical Devices

Live online

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.

  • 12 CPD hours Focused
  • Presented by Annette Callaghan
  • Next: 15 Jul 2024 Live online
  • Also: 19 Nov 2024 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide 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 after June 2023.

  • 6 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 17-18 Jul 2024 Live online
  • Also: 18-19 Nov 2024 Live online

Understanding Active Pharmaceutical Ingredients (APIs)

Live online

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It 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.

  • 12 CPD hours Focused
  • Presented by Farah Nadeem
  • and Paul Palmer
  • Next: 24-25 Jul 2024 Live online
  • Also: 25-26 Nov 2024 Live online

Understanding Computer System Validation (CSV)

Live online

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. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

  • 12 CPD hours Focused
  • Presented by Farah Nadeem
  • and Paul Palmer
  • Next: 12 Jul 2024 Live online
  • Also: 27 Nov 2024 Live online

US FDA - Understanding Key Factors When Working with the FDA

New for 2024

Live online

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.  

  • 6 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 10-11 Jun 2024 Live online
  • Also: 28-29 Nov 2024 Live online

Variations to Marketing Authorisations

Live online

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.

  • 12 CPD hours Focused
  • Presented by Andrew Willis
  • Next: 11-12 Jul 2024 Live online
  • Also: 26-27 Nov 2024 Classroom

Veterinary Pharmaceutical Submissions in the EU

Classroom, Live online

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.

  • 12 CPD hours Focused
  • Presented by Andrew Hewitt
  • and Dave Parry
  • Recorded webcast

Human Factors - The Increasing Importance of Instructions for Use

Free

Recorded webcast

This free webinar will focus on the often overlooked but increasingly important area of Instructions for Use for medical products. From the perspective of human factors and usability engineering, Instructions for Use significantly impact the performance of the user to use medical devices safely and effectively and often are only used when the user has a problem. The webinar will look at why we need Instructions for Use to be usable, not only for safety but for regulatory approval and how you achieve that. It will address what predictions can be made from existing data and discuss what the future of Instructions for Use could be. This is an excellent opportunity to learn more about this important element of your regulatory submission.

  • 1.5 CPD hours High impact
  • Presented by Greg Thay
  • Self-paced

Understanding the Pharmaceutical Industry

Self-paced

A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.

  • John Ansell