Life Sciences Training Courses

Advanced Veterinary Pharmacovigilance

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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

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

An Essential Overview of Pharmacovigilance

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A practical guide to understanding the role of pharmacovigilance.

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 ISO 22716 - GMP for Cosmetic Products

New for 2023

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This course has been designed to provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies/personnel considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements. The programme will cover all aspects of the ISO 22716 standard and will include practical application examples. The critical points to be considered in the cosmetic production process will be addressed and there will be plenty of time to discuss the complexities involved.

An Introduction to Quality Management for Managers

New for 2023

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This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

An Introduction to the Design and Development of Medical Devices

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

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.

Biosimilars

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

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)

Clinical Quality Management Systems

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

Clinical Research - A Different Approach to Successful Project Delivery

New for 2023

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Project management is not standing still, new ideas and ways of looking at project delivery are constantly changing. This workshop is designed to help you think differently about clinical research projects. Some of the concepts like System Thinking, the Theory of Constraints and Agile Project Management are not new but are often untried in our heavily regulated environment. Other techniques like Relational Risk and Complexity are very much at the forefront of current research. This course will provide you with key techniques to apply during your clinical research project to aid successful delivery.

Clinical Trial Monitoring

New for 2023

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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

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Focused

This course will provide a comprehensive overview to Cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will cover the applicable legislation, the regulatory requirements, what needs to be reported, the role of the Responsible Person, borderline products and promotional claims. Essentially 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

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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.

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.

Development of Combination Products: Critical Interactions

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

Drug Discovery: A Step-by-Step Introduction

New for 2023

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The 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 Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted 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 discovery project.

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

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Practical guidance on borderline Issues and combination products

Effective Technical Writing & Editing

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

EU Clinical Trial Regulation 536/2014: Overview and Implementation

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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

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

New for 2023

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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.

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.

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

GMP Fundamentals

New for 2023

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This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

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.

Introduction to Veterinary Pharmacovigilance

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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*

Managing Vendor/CRO/CMO Oversight

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Optimising oversight for inspection compliance

Masterclass: Artificial Intelligence-enabled Medical Devices

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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.

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 Studies: Clinical Evidence

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

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

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

Medical Writing for Medical Devices

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

Metered Dose Inhaler (MDI) Technology

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

Metrics and Earned Value in Clinical Research Projects

New for 2023

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Masterclass

The above quotation from Michael Hammer is as valid today as it was when he first said it. This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. The session will look at deliverables and the important part that they play in the calculation of the Earned Value (EV), which is the ultimate leading metric and key performance indicator (KPI) for project progress. A valuable master class for anyone involved in clinical research.

Pharmaceutical Development of ATMPs

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

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 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

Pharmacovigilance

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

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

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

New for 2023

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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.

Pharmacovigilance QMS & Inspection Preparation

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

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2023

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Focused

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

Pre-Filled Syringes: End-to-End Processing

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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.

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 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.

Signal Detection and Regulatory Expectations

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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

Smart Packaging and Electronic Patient Information

New for 2023

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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.

Stability Testing of Pharmaceuticals and Biopharmaceuticals

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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.

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 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.

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 Summer 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.

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 key factors when working with the FDA.  It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes 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.