The pandemic created numerous challenges across all areas of business worldwide and life science companies responded very quickly. Now, as the healthcare sector emerges stronger and with renewed leadership, the industry can continue to focus on key areas for development and explore ways to challenge existing processes, harness collaborations and build resilience.
Our product portfolio has been designed to focus on latest developments and best practice, covering key topics across the pharmaceutical lifecycle, including clinical, regulatory, pharmacovigilance, medical technology, medical writing and biopharma.
Live online, Classroom
Focused
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Presented by Mrs Anna Harrington-Morozova
Live online
Focused
This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.
Presented by Dr Mel Munro
and Dr Tamsin Dawson
Live online, Classroom
Focused
This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.
Presented by Dr Graeme Ladds
Live online, Classroom
Focused
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Dr Graeme Ladds
Live online
Focused
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.
Presented by Dr Eliana Henríquez Rodríguez
+ 4 more
Live online, Classroom
Focused
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
Presented by Dr Graeme Ladds
Live online
Focused
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Presented by Ms Janette Benaddi
and Ms Theresa Jeary
Live online, Classroom
Focused
Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
Presented by Mr Declan O'Rourke
Bespoke
In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring
Live online
Focused
A practical guide to understanding the role of pharmacovigilance.
Presented by Dr Graeme Ladds
Live online
Focused
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.
Presented by Dr David Jefferys
and Ms Theresa Jeary
Bespoke
High impact
This short and concise webinar will provide the essentials of how medical devices and diagnostics are regulated. With changes being introduced this summer, this is an event you cannot afford to miss! 90 minute live webinar 14:00 (UK/London Time Zone)
Live online
Focused
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Dr Laura Brown
Live online
Focused
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.
Presented by Mr Chris Penfold
Live online, Classroom
Focused
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by Mr David Howlett
Live online, Classroom
Focused
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
Presented by Ms Janette Benaddi
+ 2 more
Bespoke
An introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development.
Live online, Classroom
Focused
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Dr Laura Brown
Classroom
Focused
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions
Presented by Mr Philip Clay
Live online, Classroom
Focused
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Presented by Marloes van der Geer
Live online, Classroom, International
Focused
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by Dr Adekunle Onadipe
Live online
Focused
This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
Presented by David Richardson
Bespoke
Brexit Update - What will happen next? 14.15 (GMT)
Live online, Classroom
Focused
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Presented by Dr Laura Brown
Live online, Classroom
Focused
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Ms Janette Benaddi
Live online
Focused
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)
Presented by Dr John Price
Live online
Focused
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Dr Laura Brown
Live online
Focused
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.
Presented by Dr Laura Brown
Live online, Classroom
Focused
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Presented by Hans van Bruggen
+ 2 more
Bespoke
Focused
Live online, Classroom
Focused
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
Presented by Dr Laura Brown
Bespoke
This *In-house* course will provide a comprehensive introduction to the entire development programme for companion animal medicines.
Live online, Classroom
Focused
Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.
Live online, Classroom
Focused
Practical guidance on borderline Issues and combination products
Presented by Dr David Jefferys
Live online, Classroom
Focused
A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design *FULLY UPDATED PROGRAMME*
Presented by Mr David Howlett
+ 2 more
Bespoke
This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.
Bespoke
This unique two-day *In-house* workshop will give you key insights into how the global, regional and national codes of practice work together to form a framework for compliance.
Live online, Classroom
Focused
Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.
Presented by Ms Barbara Grossman
Live online, Classroom
Focused
The ‘how to’ of technology transfer across the product lifecycle
Presented by Mr Bruce Davis
Live online, Classroom
Focused
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU
Presented by Dr Laura Brown
Live online, Classroom
Focused
The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations. The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.
Presented by Mrs Norah Lightowler
Bespoke
Acquire key skills to maximise success in an expanding herbal product market.
Live online, Classroom
Focused
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Presented by Dr Jonathan Hughes
Live online, Classroom
Focused
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Presented by Maikel Bouman
and Marloes van der Geer
Live online, Classroom
Focused
This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments
Presented by Dr Laura Brown
Bespoke
This one-hour *webinar* will help you understand what the impact of GDPR has been on drug development 25 February 2019 - 2pm (GMT)
Live online, Classroom
Focused
Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Presented by Mr Richard Featherstone
Bespoke
Understand the impact of IP on pharmaceutical regulatory strategy
Bespoke
In this *In-house* course, discover how to develop veterinary pharmaceuticals and vaccines, its regulatory landscape and how you might apply these principles to novel biotherapeutics.
Live online
Focused
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Presented by Nancy Consterdine
and Stuart Angell
Live online, Classroom
Focused
A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*
Presented by Mr Declan O'Rourke
Bespoke
Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971 'Application to Risk Management to Medical Devices'.
Bespoke
An *In-house* GMP QPs programme providing up-to-date and detailed guidance for current, trainee and returning QPs, to help them fulfil their duties effectively and efficiently in the pharmaceutical Industry.
Live online, Classroom
Focused
Optimising oversight for inspection compliance
Presented by Dr Laura Brown
Bespoke
Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.
Live online, Classroom
Focused
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
Live online, Classroom
Focused
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Presented by Mr Koen Cobbaert
and Mrs Zuzanna Kwade
Live online, Classroom
Focused
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Ms Janette Benaddi
Live online, Classroom
Focused
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Presented by Ms Janette Benaddi
Live online, Classroom
Focused
How to produce quality regulatory documents including the clinical evaluation report (CER)
Presented by Ms Barbara Grossman
and Ms Janette Benaddi
Live online, Classroom
Focused
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by Mr David Howlett
Live online, Classroom
Focused
A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.
Presented by PhD Anders Fuglsang
Live online, Classroom
Focused
Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
Presented by Dr David Jefferys
+ 2 more
Bespoke
Focused
Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit *NEW EVENT!*
Presented by Mr Declan O'Rourke
Live online, Classroom
Focused
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Bespoke
Protect your business by ensuring your legal team understand the impact and implications of recent legal changes and updates within the pharmaceutical industry with this *In-house* training programme.
Live online, Classroom
Focused
This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.
Presented by Mr Christopher Waterhouse
Live online
Focused
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Live online
Focused
This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan
Live online
Focused
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Live online
Focused
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Mrs Anna Harrington-Morozova
Live online
Focused
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Bespoke
This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.
Live online, Classroom
Focused
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
Bespoke
This course will provide you with practical advice on preparing an effective audit report to ensure your readers understand the findings and the key messages you are trying to convey. Examples of common issues and pitfalls will be discussed to enable you to improve your audit writing skills.
Live online, Classroom
Focused
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Presented by Dr Graeme Ladds
Live online
Focused
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Dr Graeme Ladds
Live online, Classroom
Focused
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
Presented by Dr Julian Braidwood
and Ms Marie-Pascale Tiberghien
Live online
Focused
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Presented by Andreas Rothmund
+ 2 more
Live online, Classroom
Focused
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Presented by Mr Bruce Davis
Live online
Focused
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
Presented by Dr Elinor McCartney
Bespoke
This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.
Live online, Classroom
Focused
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Presented by Mrs Norah Lightowler
Live online, Classroom
Focused
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer
Bespoke
Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures
Live online
Focused
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.
Presented by Dr Laura Brown
Live online, Classroom
Focused
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
Presented by Dr Graeme Ladds
Live online
Focused
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
Presented by Ray Munden
Live online, Classroom
Focused
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.
Presented by Ms Barbara Grossman
Live online
Focused
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
Presented by Paul Sim
and Mr Will Burton
Bespoke
Practical tips on introducing a compliant pharmacovigilance system
Bespoke
The very latest information and operational experiences to be shared. 90 minute live webinar 14:00 (UK/London Time Zone)
Bespoke
The very latest information and operational experiences to be shared. 90 minute live webinar 14:00 (UK/London Time Zone)
Live online, Classroom
Focused
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Live online
Intensive
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
Presented by Ms Janette Benaddi
Live online
Focused
The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.
Presented by Dr Julian Braidwood
Self-paced
A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.
Mr John Ansell
Live online
Focused
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.
Presented by Marloes van der Geer
Live online
Focused
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.
Presented by Dr Julian Braidwood
Live online
Intensive
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Presented by David Petrick
and Dr Julian Braidwood
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