Pharmaceutical Training Courses

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 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.

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

This interactive two-day course has been designed to provide you with a thorough understanding of both technical and interpersonal project management skills. 

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

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.

A practical guide to understanding the role of pharmacovigilance.

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 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.

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.

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.

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

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

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.

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.

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

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 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.

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.

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.

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

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

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.

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

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.

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

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

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

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.

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

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

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.

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.

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

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

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.

Master the management of pharmaceutical deviations to ensure product quality, safety, and compliance. Discover key steps, industry best practices, and regulatory requirements to prevent risks and drive continuous improvement.

This two-day interactive course covers the essential interpersonal skills needed to excel as a life sciences project manager.

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

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

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

Master pharmaceutical packaging fundamentals in this course. Whether you're a beginner or in need of a refresher, learn material selection, regulatory compliance, and testing requirements from an industry expert with 25+ years' experience.

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).

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

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

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

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

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.

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure, is probably one of the most challenging managerial roles of any industry today.

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 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.

In this talk, explore how the Pharmaceutical Quality System (PQS) impacts the financials of an organisation and how it can enhance an organisation's financial strength.

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.

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.

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

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.

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

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 essential course will explain the importance of using risk management techniques in clinical trials to comply with the latest focus on inspection in this area.

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 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 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 interactive training skills and processes in pharma course is ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).

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.

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.

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

In this talk, explore how the Validation Master Plan (VMP) impacts the financials of an organisation and discover how a well managed VMP enhances an organisation’s financial strength.

Master the essentials of change control in pharmaceutical manufacturing to ensure quality and regulatory compliance. Discover key processes, change types, and industry regulations to maintain high standards.

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.

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

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

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.

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

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

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

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

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

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. 

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.

Optimising oversight for inspection compliance.

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

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

This course will help participants learn to communicate and influence more effectively within the pharma and biopharma industries.

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

Explore how GMP impacts an organisation’s finances – does it hinder innovation and add costs, or unlock potential and boost financial health?

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

This course provides an overview for senior managers of the key post-market pharmacovigilance activities required to further understand the 2012 EU legislation that has undergone over 20 updates in the last 10 years.

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 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.

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

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

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

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.

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.

In this talk, explore how the Quality Risk Management (QRM) impacts the financials of an organisation and how it can enhance an organisation's financial strength.

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

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.

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.

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.

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.

A two-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

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

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.

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

In this talk, explore how change management impacts the financials of an organisation and how well-managed change management can enhance an organisation's financial strength.

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.

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 comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

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

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

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.

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.

Discover how regulatory compliance and best practices in pharmaceutical storage and distribution ensure safe, effective medicines, with a focus on the vital role of 3PL suppliers in optimising supply chain efficiency.

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.

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

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.

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals.

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.

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.

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.

This highly effective four module webinar aims to help delegates to develop and hone their skills in resolving and managing conflict.