Pharmaceutical Training Courses

In this exciting new course, gain an introduction into the transformative impact of artificial intelligence on drug safety and monitoring.

This course equips attendees with practical strategies to enhance the clarity, impact, and ethical compliance of their publications.

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

AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.

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.

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

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

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

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.

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

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

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.  

This intensive half-day programme focuses on CTAs in the life sciences sector where legal, policy and IP considerations underpin this highly regulated area.

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

Whether you’re looking to optimise existing processes or lay groundwork for a digital transformation, the course will teach the tools to leverage Digital CMC as a cornerstone of Pharma 4.0 success.

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

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

Delve into the world of additional Risk Minimization Measures (aRMMs) and explore everything from the regulatory framework surrounding aRMMs to their impact on patient safety and healthcare outcomes.

This training will equip attendees with the practical skills necessary to implement regulatory-compliant distribution and storage systems, ensuring both pharmaceutical integrity and patient safety.

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

In this one-day course, understand everything from the role of medical information to the guidelines for medical information and advertising.

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

In this talk, explore the fundamental concepts, techniques, and processes that make up the backbone of biomanufacturing, pharmaceutical production, and biotechnology.

This course will allow participants to explore the regulatory landscapes governing AMR, discover innovative solutions and understand the challenges AMR poses across different sectors.

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

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.

This course will provide an up-to-date overview of current European pharmaceutical legislation and the regulatory impact of the proposed changes.

This introductory course provides a clear and practical foundation in toxicology. It covers key principles, terminology and testing methods, helping participants confidently interpret and apply toxicological data in chemical safety and compliance contexts.

Advance your expertise in protein engineering with this comprehensive course. Learn cutting-edge techniques in therapeutic development, biotechnology applications, and regulatory compliance, ideal for professionals in pharmaceutical and industrial sectors.

Master CRISPR genome editing fundamentals and real-world applications in medicine, research, and biotechnology with expert-led training and certification.

Master pharmaceutical packaging essentials in 3 days: materials selection, regulatory compliance, and testing requirements. Led by industry expert with 25+ years' experience.

A comprehensive introductory guide to signal detection in pharmacovigilance, covering its history, regulations, processes, and safety assessments.

This brand new course on the recently published and long-awaited ICH GCP E6 (R3) is designed to help participants stay compliant and implement the new guideline effectively.

This course covers Good Clinical Practice (GCP) principles, ensuring participants understand the ethical and regulatory foundations of clinical research, including integrity, safety, consent, data management, and compliance.

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.

In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

Explore the fundamental rules of scientific writing, learning how to organise and present complex research in a clear, ethical and compelling manner.

Learn to conduct thorough audits, identify non-conformities, and recommend corrective actions while following the Golden Rules of successful GMP auditing.

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

This two-day course provides an introduction to pharmaceutical regulatory affairs and the fundamentals of drug development. It is particularly valuable for those who are new to the regulatory function or work in a supporting or interactive role.

A comprehensive comparison between the importance Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) in drug safety.

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

This training programme provides essential skills for planning, managing, and executing internal Good Manufacturing Practices (GMP) audits.

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

This training provides knowledge and practical skills to effectively audit material and service providers, covering key areas including raw materials, contract manufacturing, logistics, and packaging.

Explore the microbiome and its high clinical relevance, as well as learning about the different methodology used in microbiomic clinical trials.

A one-day practical and interactive seminar focuses on everything you need to know about competition law and the pharmaceutical sector

An essential guide to scientific communication covering the essentials of scientific journals, including publishing houses, metrics and their purpose.

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 a brief review of key FDA requirements.

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

Gain practical guidance on EU and FDA regulations for drug/device combination products, along with solutions to current challenges, in this comprehensive course.

This course explores how leveraging digital solutions, companies can not only accelerate the transfer of critical knowledge but also foster innovation and gain an edge in increasingly competitive markets.

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

This training equips auditors with strategies to handle obstacles such as documentation errors, unethical behaviours, resistance, and time-wasting tactics, ensuring a smooth and productive audit process.

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

This course covers technology transfer for solid dosage forms, focusing on best practices, strategies, and real-world challenges through interactive sessions and case studies.

Documentation is crucial for regulatory compliance, ensuring accuracy and integrity in clinical trials and laboratory work. GDP has evolved over time, guided by ALCOA & ALCOA-plus principles.

Attendees will gain a comprehensive understanding of the science behind nanoparticles, their diverse applications, manufacturing and the opportunities and challenges involved in bringing nanoparticle-based solutions to market.

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

One of the most valuable tools for auditors in the pharmaceutical industry is the ability to conduct thorough and effective interviews during audits. This training will equip you with these essential skills.

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

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).

An excellent opportunity to hear from two renowned cognition experts and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes, as well as the emerging science of blood-based biomarkers.

This course will help delegates gain a better understanding of the software automation technology driving change within the clinical trials landscape.

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

Master pharmaceutical deviation management in just 1 hour. Learn root cause analysis, CAPA processes, and compliance requirements to ensure product quality and safety.

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.

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

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.

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

This course will equip you with the tools and insights needed to articulate your vision, secure funding, and pave the way for Pharma 4.0 success.

Optimising oversight for inspection compliance.

This session provides an essential guide to selecting both the best and authentic scientific journal for your research, offering practical strategies for using indexing systems and selector tools to enhance visibility and credibility.

This highly interactive and practical one-day course will introduce you to both the principles of GCP and give you an understanding of how to practically apply it in different settings.

This training course prepares professionals in pharmaceuticals, healthcare, and manufacturing to navigate regulatory inspections by major health authorities including the FDA, MHRA, WHO, and EMA.

This course provides a foundation in the critical role of signal detection in ensuring the safety and efficacy of medicines.

In this course, you will see the value of remote patient adherence monitoring and learn how to stay ahead of the curve by creating your own digital solutions. 

Master pharmaceutical change control processes in just 1 hour. Learn GxP compliance, change categories, and regulatory requirements for quality professionals.

This course covers ethical standards, data integrity, audience tailoring, document structure, clarity, consistency, citation, and tools for quality control and compliance.

Explore the applications and significance of molecular biology in the pharmaceutical industry, covering DNA, RNA, proteins, gene expression, biotechnology, drug discovery, personalised medicine, and the latest breakthroughs like CRISPR-Cas9 and mRNA vaccines.

In this webinar, we will discuss the major requirements and strategies for nitrosamines, a hot topic that is on the forefront of many company's minds.

On this course, learn the basics of writing health and medical articles for the consumer.

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

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

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.

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

The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

This course 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.

A practical guide to understanding the role of pharmacovigilance.

Through this interactive session, participants will explore the forces driving the shift toward digital transformation, understand the challenges Digital CMC addresses, and learn about its operational and regulatory advantages.

Learn how to build digital technology that is specifically aligned to match with the patient, the clinical study, the disease and the treatment programme.

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.

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

This course will provide attendees with fundamental editing skills, enabling them to refine their own research articles or edit the work of other researchers with confidence.

This two-day course covers international standards for clinical and post-marketing drug safety, including ICH guidelines, adverse event reporting, signal detection, and risk management strategies.

This course provides an overview of journal submission, including the types and steps of submissions, as well as effective pre- and post-submission communication to help participants navigate publication successfully.

This course will look at ethical research, responsible authorship, and data integrity while addressing conflicts, misconduct, and copyright issues.

This two-day course offers a thorough understanding of literature searching in drug safety, covering regulatory requirements, search criteria, and the interpretation of safety data, while also providing practical assessments to apply knowledge to real-world pharmacovigilance cases.

Master pharmaceutical compliance essentials for storage and distribution. Learn regulatory requirements, best practices, and 3PL supplier optimisation in just 1 hour.

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

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.

The ability to create a working relationship with your partners in a technology transfer is normally overlooked. In the current pharmaceutical landscape, gaining trust should never be an after thought.

This course provides the latest updates on the finalised ICH GCP E6 R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

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.

This course covers journal decision types and techniques for responding effectively to reviewers' feedback, as well as strategies for revising and resubmitting manuscripts to enhance publication success.

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.

Explore the intersection between AI and medical communications in this medical writing power hour.

This course provides a comprehensive guide to grant writing, covering funder identification, proposal development, submission strategies, post-submission processes, partnerships, technology use, and ethical considerations.

A deep dive into the importance of real world evidence (RWE), real world data (RWD) and artificial intelligence (AI) in pharmaceuticals.

This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.