Life Sciences Training Courses

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

Live online, Classroom
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.

A Practical Guide to Producing and Maintaining the PSMF

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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.

A Practical Guide to Writing Risk Management Plans (RMPs)

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Focused

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

Advanced Pharmacovigilance

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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.

Advanced Regulatory Affairs for Medical Devices

Live online, Classroom
Focused

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

Advanced Veterinary Pharmacovigilance

Live online, Classroom
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

An Essential Overview of Medical Information

Live online, Classroom
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 Pharmacovigilance

Live online, Classroom
Focused

A practical guide to understanding the role of pharmacovigilance.

An Introduction to Quality Management for Managers

New for 2022

Live online, Classroom
Focused

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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Focused

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

An Introduction to the Medical Device Regulation

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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.

Biotechnology for the Non-Biotechnologist

Live online, Classroom
Focused

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

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

New for 2022

Live online, Classroom
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.

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

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Focused

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

Clinical Quality Management Systems

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Focused

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

Clinical Trial Regulatory Requirements

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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 and key difference it compares with the Clinical Directive requirements.

Cyber Security for Medical Devices

Live online, Classroom
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. 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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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.

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

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Focused

Practical guidance on borderline Issues and combination products

Effective Technical Writing & Editing

Live online, Classroom
Focused

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

Effective Technology Transfer

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Focused

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

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online, Classroom
Focused

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

EU Pharmaceutical Regulations & Strategy

Live online, Classroom
Focused

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

European Post Marketing Pharmacovigilance

New for 2022

Live online, Classroom
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.

FDA Approval Process for Medical Devices

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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.

GCP and Clinical Research Update - Hot Inspection Topics

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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

GMP Fundamentals

New for 2022

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Focused

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.

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

Live online, Classroom
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.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online, Classroom
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.

Introduction to Veterinary Pharmacovigilance

Live online, Classroom
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*

Managing Vendor/CRO/CMO Oversight

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Focused

Optimising oversight for inspection compliance

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

Live online, Classroom
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.

Medical Device Regulations in the Middle East and North Africa

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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

Medical Device Single Audit Programme (MDSAP)

New for 2022

Live online, Classroom
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.

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

Live online, Classroom
Focused

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

Medical Device Studies: Clinical Evidence

Live online, Classroom
Focused

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

Live online, Classroom
Focused

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

Live online, Classroom
Focused

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

Metered Dose Inhaler (MDI) Technology

Live online, Classroom
Focused

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

New Regulations for Medical Devices and IVDs in Europe

Live online, Classroom
Focused

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

Pharmaceutical Development of ATMPs

Live online, Classroom
Focused

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

Pharmaceutical Regulatory Affairs in Asia

Live online, Classroom
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

Pharmaceutical Regulatory Affairs in China

Live online, Classroom
Focused

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

Live online, Classroom
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

Live online, Classroom
Focused

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

Pharmacovigilance

Live online, Classroom
Focused

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

Live online, Classroom
Focused

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

New for 2022

Live online, Classroom
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.

Practical Implementation of GCP in Veterinary Field Studies

Live online, Classroom
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.

Process Validation with Qualification

Live online, Classroom
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.

Quality Management Refresher

New for 2023

Live online, Classroom
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

Regulatory Affairs for Support Staff

Live online, Classroom
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.

Signal Detection and Regulatory Expectations

Live online, Classroom
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

Smart Packaging and Electronic Patient Information

New for 2023

Live online, Classroom
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.

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online, Classroom
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.

Sterilization of Medical Devices

New for 2022

Live online, Classroom
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.

Successful Medical Writing

Live online, Classroom
Focused

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.

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online, Classroom
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.

Veterinary Pharmaceutical Submissions in the EU

Live online, Classroom
Focused

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.