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

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

This specialist five-day seminar running in Dubai has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

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 18th prestigious annual ‘must attend’ event has been designed specifically for Senior Patent Administrators. It provides an ideal opportunity to learn about any developments that affect you and your role, to make sure you are up to date on best-practice and are working as efficiently as possible.

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.

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

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

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

NEW EVENT!

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

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

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.

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

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.

Two-days to for legal counsel to get-to-grips with current best practice and creative value-added solutions to their legal department management challenges

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.

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

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

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

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.

A practical guide to understanding the role of pharmacovigilance

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.

One-day intensive briefing on best practice and employment law requirements for the effective HR assistant

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

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

The latest technologies in connected medical devices, digital health and mobile apps for the pharmaceutical and medical device industries

Practical tips on introducing a compliant pharmacovigilance system

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

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).

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation, technology, innovation and artwork origination.

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

PLEASE NOTE THE ORIGINAL DATE FOR THIS EVENT HAS CHANGED TO 8-9 MAY 2019

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous areas an employer regularly faces

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

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.

A two-day workshop for those who need to achieve results through personal influence.

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

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

Newly updated programme

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.

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 programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

This practical and interactive 2-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

An essential annual update for inhalation professionals. Industry case studies, regulatory updates, latest therapies and technology innovations.

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.

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

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.

Senior Trade Mark & Design Administrators, speakers from WIPO discussing the Madrid and Hague systems, from OHIM discussing the guidelines, also presentation about differences between US and EU practice and what to do about them.

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

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Achieve excellence as an HR business partner and improve your ability to increase the impact HR has on your organisation

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

NEW COURSE!

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

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

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 course that will ensure you to comply with new regulatory requirements

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

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 2019

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.

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

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

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

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

Proactively manage your contract by applying a logical and systematic approach enabling you to anticipate and resolve problems before they become critical

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

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

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

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

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

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

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

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 all 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 seminar now in its tenth successful year.

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

The programme will offer a comprehensive introduction to the new legislation Regulation (EU) 2019/6 and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers. NEW EVENT!

An updated brochure will be available shortly!

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

Including the main requirements of Volume IXB, an update on the proposed EU regulation for veterinary medicinal products and the impact of Brexit

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

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.

A two-day course for those looking to improve their decision-making and problem-solving skills within the pharma industry

NEW COURSE!

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

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

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

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

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

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

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

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

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

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

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

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.

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

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.

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

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

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

PLEASE NOTE THE ORIGINAL DATE FOR THIS EVENT HAS CHANGED TO 8-9 MAY 2019

A step by step practical guide to Strategic IP Planning

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.

Two-days to for legal counsel to get-to-grips with current best practice and creative value-added solutions to their legal department management challenges

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

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.

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 two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

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

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

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 specialist five-day seminar running in Dubai has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

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

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

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

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

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.

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 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 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)

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.

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

NEW EVENT!

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

Practical Guidance on Borderline Issues and Combination Products

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

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

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

New for 2019

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 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

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

A practical guide to understanding the role of pharmacovigilance

One-day intensive briefing on best practice and employment law requirements for the effective HR assistant

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

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 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.

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 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 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.

A two-day workshop for those who need to achieve results through personal influence.

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Achieve excellence as an HR business partner and improve your ability to increase the impact HR has on your organisation

The programme will offer a comprehensive introduction to the new legislation Regulation (EU) 2019/6 and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers. NEW EVENT!

An updated brochure will be available shortly!

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

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

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

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

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

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

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.

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

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

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous areas an employer regularly faces

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

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

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.

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

Newly updated programme

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

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

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.

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

NEW COURSE!

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

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.

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

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 programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

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

Proactively manage your contract by applying a logical and systematic approach enabling you to anticipate and resolve problems before they become critical

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

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

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

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

Including the main requirements of Volume IXB, an update on the proposed EU regulation for veterinary medicinal products and the impact of Brexit

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

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

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

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

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 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.

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 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.

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.

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

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

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

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 specialist five-day seminar running in Dubai has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

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

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

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

A step by step practical guide to Strategic IP Planning

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

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

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

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

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

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

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

PLEASE NOTE THE ORIGINAL DATE FOR THIS EVENT HAS CHANGED TO 8-9 MAY 2019

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

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.

Two-days to for legal counsel to get-to-grips with current best practice and creative value-added solutions to their legal department management challenges

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

New for 2019

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

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.

A practical guide to understanding the role of pharmacovigilance

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

One-day intensive briefing on best practice and employment law requirements for the effective HR assistant

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

NEW EVENT!

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

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.

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.

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.

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

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous areas an employer regularly faces

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.

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

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

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

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

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.

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

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 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.

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.

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 practical and interactive 2-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

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

Newly updated programme

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

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

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.

The programme will offer a comprehensive introduction to the new legislation Regulation (EU) 2019/6 and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers. NEW EVENT!

An updated brochure will be available shortly!

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

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

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

A two-day workshop for those who need to achieve results through personal influence.

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

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

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

NEW COURSE!

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

Achieve excellence as an HR business partner and improve your ability to increase the impact HR has on your organisation

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

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

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

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

Including the main requirements of Volume IXB, an update on the proposed EU regulation for veterinary medicinal products and the impact of Brexit

Proactively manage your contract by applying a logical and systematic approach enabling you to anticipate and resolve problems before they become critical

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

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

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

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.

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

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

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

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

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

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