Pharmaceutical Training Courses

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.

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

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

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

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.

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

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

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

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.

This course provides recent updates on the New ICH GCP 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.

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.

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

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.

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

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 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.

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

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

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.

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

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.

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

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

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

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

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

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.

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.

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

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

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

A comprehensive comparison between Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP).

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

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 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.

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

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

Gain practical guidance on the complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

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.

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

A practical guide to understanding the role of pharmacovigilance.

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 has been designed for those wishing to expand their knowledge in pharmacovigilance and explore what they would like to understand next in this complex area.

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.

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

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

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

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

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.

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

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

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

Optimising oversight for inspection compliance.

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.

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

This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries. "What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman

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

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

This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.

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

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.

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.

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.

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.

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.

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

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.

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

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

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

This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

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

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

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 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 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 ten years.

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

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

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

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.

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

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

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 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.

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.

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

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.

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

This course provides recent updates on the New ICH GCP 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.

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

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

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.

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 covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

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

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.

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

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.

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

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

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

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

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.

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 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.

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.

This course has been designed for those wishing to expand their knowledge in pharmacovigilance and explore what they would like to understand next in this complex area.

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.

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.

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.

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

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

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

A practical guide to understanding the role of pharmacovigilance.

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

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

Gain practical guidance on the complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

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.

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

A comprehensive comparison between Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP).

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

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

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.

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

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

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

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 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.

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.

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.

Unlock the world of pharmaceutical regulatory excellence with our Global Pharmaceutical Regulatory Affairs training – an intensive journey through the diverse regions, offering practical insights, expert guidance, and strategic mastery for professionals seeking to navigate and succeed in the dynamic global regulatory landscape.

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

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

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

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

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

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.

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

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.

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

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).

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

This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

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

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

Optimising oversight for inspection compliance.

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

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.

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

This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.

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

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).

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 emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries. "What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman

This course provides recent updates on the New ICH GCP 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.

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.

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

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.

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.

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

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 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.

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

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

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

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 5-day Summer School has been especially designed to help you transcend these challenges by training you to become equipped to see the bigger picture in all aspects of your role.

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

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

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.

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

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 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.  

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

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 ten years.

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

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.

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.

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

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.

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.

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.

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

A practical guide to understanding the role of pharmacovigilance.

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.

Gain practical guidance on the complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

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.

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 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.

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

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

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

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.

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.

A comprehensive comparison between Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP).

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.

This course has been designed for those wishing to expand their knowledge in pharmacovigilance and explore what they would like to understand next in this complex area.

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.

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).

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

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.

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

This interactive course will discuss the regulatory requirements 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.

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.

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.

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.

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

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.

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

This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.

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 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.

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

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.

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

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

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

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

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

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

This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries. "What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman

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.

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

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

This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

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.

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 ten years.

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.

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

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

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.

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

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.

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 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

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 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

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.

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 recent updates on the New ICH GCP 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.

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.

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.

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.  

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

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.