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.

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

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

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

A new comprehensive and practical two day seminar covering Patentability and State-of-the-art Searching

Understanding the background, defining terms and objectives; fundamentals of FTO search scope, methods for searching for claimed features, using basic legal status tools to assist valuation, and understanding and reporting the results from an FTO perspective.

This seminar will provide an essential overview of the key areas of requirements for approvals for Medical Devices in Latin America. Countries to be covered: Brazil, Mexico, Colombia and Peru

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

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

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

This one hour webinar will help you understand what has the impact of GDPR been on drug development

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day

A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements

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

This course will provide you with practical advice in 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.

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English Law

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and ‘mixed’ inventions with both patentable and non-patentable subject matter

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.

The programme will offer a comprehensive introduction to the legislative changes and will address the new issues, marketing authorisation (MA) submissions and dossiers. NEW EVENT!

A two-day no-nonsense plain English practical course to get-to-grips with business and contract law for busy business executives.

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

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.

The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXb, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company.

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.

Practical Guidance on Borderline Issues and Combination Products

This two-day course will challenge your current thinking and behaviour in all areas of communication.
 
 
 

Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!

A step by step practical guide to Strategic IP Planning.

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

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

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe

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 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 seminar will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark

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.

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

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

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting

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.

Understand the importance of accuracy and attention to detail in day-to-day work

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

Communicate, influence and motivate to enhance internal and external relationships and to help improve both yours and the business performance.

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

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.

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology.

This conference gives a comprehensive review within the field of nasal drug delivery while reviewing the very latest new data and innovative technologies.

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

This meeting 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.

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.

Understand the impact of IP on pharmaceutical regulatory strategy

Brand new course for 2018

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

This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits

This two-day workshop is for those new to negotiations or for those who wish to refresh and/or enhance their existing negotiation skills.

Aquire key skills in maximising success in an expanding herbal product market

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices

This 3-day accelerated management programme will provide you with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with pharma case studies from business schools.

Some of the topics to be covered at this meeting include an overview of the legal/policy landscape as it affects the terms of CTAs, clause-by-clause review, legal clauses, review of a University’s CTA

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

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.

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.

How to Avoid Common Pitfalls in Combined EU/US Patent Applications. This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.

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

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.

Brochure will be available shortly.

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

New for 2018

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 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.

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

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

Licensing agreements are frequently used by commercial entities, public or quasi-public bodies for the development of new business prospects and cross-border expansion.

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

New course for 2018

A 3-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 will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Effectively communicate, negotiate, influence and persuade to build your personal brand and positively impact personal and business performance in this intensive two-day development programme

Proactively manage the legal and commercial considerations essential for securing a successful international agreement

This course will give you a comprehensive introduction to the role of the Patent Administrator

This practical four day course provides a comprehensive understanding of a veterinary medicine development in the EU and USA.

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem/solution-approach, giving delegates an edge over other parties.

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.

A practical interactive three day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills

This interactive one day course will provide an introduction to mindfulness and encourage new ways of thinking and working, as well as help you relate to stress and problems in a different way.

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.

Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

A two-day no-nonsense plain English practical course to get-to-grips with business and contract law for busy business executives.

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

NEW COURSE

A two-day seminar for Administrative Staff in the Patent Profession on how to competently prepare an application for filing before the EPO

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

An essential course for ensuring compliance with Regulatory Requirements which will be of particular relevance for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP, QA and Document Management Functions

This meeting 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

This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills

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.

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

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

A concise one-day seminar about the key principles of delegation, its link to motivation and impact on productivity.

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.

This course will provide you with practical advice in 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.

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.

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and ‘mixed’ inventions with both patentable and non-patentable subject matter

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

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English Law

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

Practical Guidance on Borderline Issues and Combination Products

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day

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.

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

A step by step practical guide to Strategic IP Planning.

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

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.

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

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

This course provides an essential overview 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 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

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology.

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

The programme will offer a comprehensive introduction to the legislative changes and will address the new issues, marketing authorisation (MA) submissions and dossiers. NEW EVENT!

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Dealing with difficult people. This meeting will cover discovering why people are difficult, recognising classic profiles of difficult people, pre-empting challenging situations and avoid escalation, enhancing your own attributes, developing your copying strategies

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting

The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXb, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company.

Conflict is an inevitable part of life. This interactive seminar will help provide added skills for when conflict has arisen and there is a need to build confidence and de-escalate the confrontation

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.

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

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

A new comprehensive and practical two day seminar covering Patentability and State-of-the-art Searching

Understanding connected medical devices, medical mobile Apps and the Medical Device Internet of Things

Understanding the background, defining terms and objectives; fundamentals of FTO search scope, methods for searching for claimed features, using basic legal status tools to assist valuation, and understanding and reporting the results from an FTO perspective.

This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

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

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

Interactive course ideal for anyone with responsibility for planning or delivering training in the Pharma, Device or Animal Health Industries (including GXP and SOP training to comply with EU and FDA inspection requirements).

There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.

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.

This seminar will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark

A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements

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 course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.

This 3-day accelerated management programme will provide you with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with pharma case studies from business schools.

Licensing agreements are frequently used by commercial entities, public or quasi-public bodies for the development of new business prospects and cross-border expansion.

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.

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

Effectively communicate, negotiate, influence and persuade to build your personal brand and positively impact personal and business performance in this intensive two-day development programme

Proactively manage the legal and commercial considerations essential for securing a successful international agreement

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem/solution-approach, giving delegates an edge over other parties.

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.

This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

NEW COURSE

Creating a team that speaks and acts with one vision in the pharma/device/animal health industries

Understand the impact of IP on pharmaceutical regulatory strategy

Brand new course for 2018

This course will give you a comprehensive introduction to the role of the Patent Administrator

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

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

New for 2018

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.

Brochure will be available shortly.

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

This two day programme will give you a detailed understanding of the PCT mechanism beyond the basics with practical tips and advice on how to make most efficient use of ePCT

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

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

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

New course for 2018

A two-day no-nonsense plain English practical course to get-to-grips with business and contract law for busy business executives.

A two-day seminar for Administrative Staff in the Patent Profession on how to competently prepare an application for filing before the EPO

An essential course for ensuring compliance with Regulatory Requirements which will be of particular relevance for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP, QA and Document Management Functions

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

This meeting 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

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

Two day meeting on Regulation Update on Animal Feed and Feed Additives in the EU, USA and China, annual conference now in its 6th successful year.

This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills