Life Sciences Training Courses

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

Variations to Marketing Authorisations

Live online
Focused

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.

Delivery of Biologics to the Nasal Cavity

New for 2023

Live online
Focused

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers

Free

Live online
High impact

This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

The Medical Device School - From Concept to CE Marking

Summer school

Live online
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.

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

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

The FDA Drug Approval Process

Live online
Focused

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

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

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

Registration of Animal Feed Additives in the EU

Live online
Focused

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

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

FDA Approval Process for Medical Devices

Live online
Focused

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.

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

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

Biotechnology for the Non-Biotechnologist

Live online
Focused

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Regulatory Strategies for Orphan Drugs

Live online
Focused

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

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

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)

Introduction to Veterinary Pharmacovigilance

Live online
Focused

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

Effective Technical Writing & Editing

Live online
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

GCP and Clinical Research Update - Hot Inspection Topics

Live online
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments and update on the New ICH GCP R3 guideline.

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

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

Live online
Focused

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.

Pharmaceutical Regulatory Affairs in China

Live online
Focused

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

Medical Device Single Audit Programme (MDSAP)

New for 2023

Live online
Focused

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.

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

New for 2023

Live online
Focused

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.

Masterclass: Artificial Intelligence-enabled Medical Devices

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

The Common Technical Document

Live online
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

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

Live online
Focused

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.

An Essential Overview of the Medical Device Industry

Live online
Focused

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.

Understanding Pharmacovigilance Regulations in APAC

New for 2023

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

Biosimilars

Live online
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Cyber Security for Medical Devices

Live online
Focused

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.

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Practical Implementation of GCP in Veterinary Field Studies

Live online
Focused

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

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

Live online
Focused

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.

Best Practice for Writing Effective SOPs

Live online
Focused

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

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online
Focused

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.

Effective Technology Transfer

Live online
Focused

The ‘how to’ of technology transfer across the product lifecycle

CAPA (Corrective and Preventative Action)

Live online
Focused

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.

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

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

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

New for 2023

Live online
Focused

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.

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2023

Live online
Focused

This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding and update from Go Live from 2022 to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

Pharmacovigilance Aspects of Licensing Agreements

Live online
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Filing eCTD Submissions

Live online
Focused

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

Data Integrity and Document Management

Live online
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

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

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online
Focused

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

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.

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

New for 2023

Live online
Focused

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.

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

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

New for 2023

Live online

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.

An Introduction to the Medical Device Regulation

Live online
Focused

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.

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

An Essential Overview of Pharmacovigilance

Live online
Focused

A practical guide to understanding the role of pharmacovigilance.

Registration of Veterinary Vaccines in the USA and Canada

Updated for 2023

Live online

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.

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

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

Clinical Trial Regulatory Requirements

Live online
Focused

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation one year on and a brief review of key FDA requirements.

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

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

New for 2023

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.

Advanced Pharmacovigilance

Live online
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Artificial Intelligence and Machine Learning Powered Signal Management

New for 2023

Live online
Focused

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

New for 2023

Live online

An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

Drug Discovery: A Step-by-Step Introduction

New for 2023

Live online
Focused

This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.

Metered Dose Inhaler (MDI) Technology

Live online
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Regulatory Affairs for Support Staff

Live online
Focused

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.

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2023

Live online
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.

Process Validation with Qualification

Live online
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Metrics and Earned Value in Clinical Research Projects

New for 2023

Live online
Masterclass

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

The FDA Drug Approval Process

Live online
Focused

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

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

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

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge

New for 2023

Live online
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

Effective Technical Writing & Editing

Live online
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Introduction to Veterinary Pharmacovigilance

Live online
Focused

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

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)

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

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

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Clinical Research - A Different Approach to Successful Project Delivery

New for 2023

Live online

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

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

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

Cosmetovigilance

Updated for 2023

Live online
Focused

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

Cyber Security for Medical Devices

Live online
Focused

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.

Delivery of Biologics to the Nasal Cavity

New for 2023

Live online
Focused

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

Understanding Pharmacovigilance Regulations in APAC

New for 2023

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

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

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Variations to Marketing Authorisations

Live online
Focused

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.

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

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.

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

EU Pharmaceutical Regulations & Strategy

Live online
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

Live online
Focused

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

Advanced Veterinary Pharmacovigilance

Live online
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

Sterilization of Medical Devices

New for 2023

Live online
Focused

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.

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2023

Live online
Focused

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

US FDA - Understanding Key Factors When Working with the FDA

New for 2023

Live online
Focused

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.  

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

New for 2023

Live online
Focused

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.

Regulatory Strategies for Orphan Drugs

Live online
Focused

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

Biosimilars

Live online
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

An Introduction to the Medical Device Regulation

Live online
Focused

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.

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

European Post Marketing Pharmacovigilance - Including the EMA/PRAC deliberations and Brexit implications

New for 2023

Live online
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

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.

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Masterclass: Artificial Intelligence-enabled Medical Devices

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

An Essential Overview of the Medical Device Industry

Live online
Focused

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.

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding and update from Go Live from 2022 to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

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

Live online
Focused

Practical guidance on borderline Issues and combination products

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

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.

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

UK Conformity Assessed (UKCA) Marking for Medical Devices

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Focused

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.

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2023

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This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.

Medical Writing for Medical Devices

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How to produce quality regulatory documents including the clinical evaluation report (CER)

GCP and Clinical Research Update - Hot Inspection Topics

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This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments and update on the New ICH GCP R3 guideline.

The Common Technical Document

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A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

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.

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.

Pharmacovigilance Aspects of Licensing Agreements

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This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

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Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

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.

Data Integrity and Document Management

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Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

An Essential Overview of Medical Information

Updated for 2023

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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

FDA Approval Process for Medical Devices

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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.

The Medical Device School - From Concept to CE Marking

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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.

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

Biotechnology for the Non-Biotechnologist

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An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Successful Medical Writing

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Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

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

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

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.

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

Advanced Pharmacovigilance

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This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

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.

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.

Understanding Pharmacovigilance Regulations in APAC

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Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

Artificial Intelligence and Machine Learning Powered Signal Management

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Focused

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

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

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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.

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

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An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

Understanding Pharmacovigilance Regulations in APAC

Live online
Focused

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

Artificial Intelligence and Machine Learning Powered Signal Management

Live online
Focused

This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

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An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.