Regulatory Affairs Training Courses

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

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Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China

Advanced Regulatory Affairs for Medical Devices

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Focused

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

An Essential Overview of Medical Information

Updated for 2023

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Focused

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

An Essential Overview of the Medical Device Industry

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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.

An Essential Overview of the Pharmaceutical and Biotech Industries

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

An Introduction to the Medical Device Regulation

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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.

Best Practice for Writing Effective SOPs

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

CAPA (Corrective and Preventative Action)

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

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

New for 2023

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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.

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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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)

Cyber Security for Medical Devices

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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.

Drug/Device and Device/Drug Combinations in the EU and USA

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Practical guidance on borderline Issues and combination products

EU Pharmaceutical Regulations & Strategy

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Focused

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

Filing eCTD Submissions

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This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

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

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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.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

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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.

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

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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.

Medical Device Regulations in the Middle East and North Africa

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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

Medical Device Single Audit Programme (MDSAP)

New for 2023

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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.

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

New for 2023

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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.

Pharmaceutical Regulatory Affairs in Africa

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

Pharmaceutical Regulatory Affairs in Asia

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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

Pharmaceutical Regulatory Affairs in China

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

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

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Focused

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

Pharmaceutical Regulatory Affairs in the Middle East

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

Registration of Animal Feed Additives in the EU

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This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Registration of Veterinary Vaccines in the USA and Canada

Updated for 2023

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This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

Regulatory Affairs for Support Staff

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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.

Regulatory Strategies for Orphan Drugs

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

Risk Management for Pharma and Biopharma Professionals

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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.

Sterilization of Medical Devices

New for 2023

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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.

The FDA Drug Approval Process

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

The Medical Device School - From Concept to CE Marking

Summer school

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Intensive

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.

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

New for 2023

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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.

UK Conformity Assessed (UKCA) Marking for Medical Devices

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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.

Understanding Active Pharmaceutical Ingredients (APIs) - A Comprehensive and Practical Introduction

New for 2023

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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.

Understanding Computer System Validation (CSV) - A Comprehensive and Practical Introduction

New for 2023

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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.

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2023

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High impact

‘Better regulation…for better trials…for better health’ The Medicines and Healthcare products Regulatory Agency (MHRA) have set far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. This webinar will bring you up-to-date with the current position regarding the proposals and the potential implications and opportunities for the industry.

US FDA - Understanding Key Factors When Working with the FDA

New for 2023

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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.  

Variations to Marketing Authorisations

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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.