Calendar

September 2018

General introduction and important information on FDA Procedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

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

Contract Law 2018 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Contract Law Update

19 Sep 2018

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

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.

This programme highlight the different perspectives of academic parties, commercial parties and institutional funding bodies and explain some of the legal issues affecting R&D agreements.

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 two day course which has been designed specifically for those working in a support staff role provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development.

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

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 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

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

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

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

25-27 Sep 2018

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.

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

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 provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience

This 17th 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.

October 2018

Pharmaceutical Regulatory Affairs in Africa including South Africa, Algeria ,Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Nigeria, Namibia, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe

Book by 17 Aug to save
£200 / €280 / $312

Advanced Veterinary Pharmacovigilance – the purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.

Book by 17 Aug to save
£200 / €280 / $312

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

Book by 17 Aug to save
£200 / €280 / $312

Advances in wearable drug delivery, this conference will review the current trends in the market and highlight the latest technology in this fast growing area.

Book by 24 Aug to save
£200 / €280 / $312

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

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.

Book by 17 Aug to save
£200 / €280 / $312

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

Book by 31 Aug to save
£100 / €140 / $156

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

Book by 31 Aug to save
£100 / €140 / $156

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.

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.

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

Book by 24 Aug to save
£100 / €140 / $156

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.

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 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.

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

Book by 17 Aug to save
£200 / €280 / $312

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.

Book by 24 Aug to save
£200 / €280 / $312

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.

Book by 17 Aug to save
£100 / €140 / $156

Practical Guidance on Borderline Issues and Combination Products

Book by 24 Aug to save
£200 / €280 / $312

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.

Book by 24 Aug to save
£200 / €280 / $312

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.

Book by 24 Aug to save
£200 / €280 / $312

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

Book by 5 Sep to save
£200 / €280 / $312

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

Book by 17 Sep to save
£100 / €140 / $156

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

Book by 17 Sep to save
£100 / €140 / $156

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

Book by 11 Sep to save
£200 / €280 / $312

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

Book by 24 Aug to save
£200 / €280 / $312

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 GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and CVMP.

Book by 20 Sep to save
£200 / €280 / $312

November 2018

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).

Book by 20 Sep to save
£200 / €280 / $312

This annual conference will include case studies, regulatory updates, latest therapies and technology innovations in two information packed days

Inhaled Drug Delivery

1-2 Nov 2018

Book by 24 Aug to save
£200 / €280 / $312

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.

The Pharma Mini MBA

5-7 Nov 2018

Book by 24 Aug to save
£300 / €420 / $468

Understand the impact of IP on pharmaceutical regulatory strategy

Brand new course for 2018

Book by 21 Sep to save
£100 / €140 / $156

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

Book by 24 Aug to save
£200 / €280 / $312

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

Book by 11 Sep to save
£200 / €280 / $312

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.

Book by 20 Sep to save
£200 / €280 / $312

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

Book by 11 Sep to save
£200 / €280 / $312

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.

Book by 21 Sep to save
£100 / €140 / $156

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.

Book by 5 Oct to save
£200 / €280 / $312

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

Book by 21 Sep to save
£100 / €140 / $156

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

Book by 19 Sep to save
£100 / €140 / $156

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.

Book by 5 Oct to save
£300 / €420 / $468

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

New for 2018

Book by 5 Oct to save
£200 / €280 / $312

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

Book by 13 Sep to save
£100 / €140 / $156

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products.

Book by 5 Oct to save
£200 / €280 / $312

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.

Book by 5 Oct to save
£100 / €140 / $156

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.

Book by 5 Oct to save
£100 / €140 / $156

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

Book by 21 Sep to save
£100 / €140 / $156

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

Book by 20 Sep to save
£200 / €280 / $312

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

Book by 13 Sep to save
£300 / €420 / $468

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

Book by 5 Oct to save
£200 / €280 / $312

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

Book by 20 Sep to save
£200 / €280 / $312

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

Book by 5 Oct to save
£100 / €140 / $156

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

Book by 20 Sep to save
£200 / €280 / $312

This course is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.

Book by 21 Sep to save
£200 / €280 / $312

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

Book by 5 Oct to save
£200 / €280 / $312

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

Book by 20 Sep to save
£200 / €280 / $312

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.

Book by 28 Sep to save
£200 / €280 / $312

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

Book by 12 Oct to save
£200 / €280 / $312

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

Book by 12 Oct to save
£200 / €280 / $312

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

Business and Contract Law

28-29 Nov 2018

Book by 3 Oct to save
£200 / €280 / $312

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

Advanced PCT Formalities

29-30 Nov 2018

Book by 5 Oct to save
£200 / €280 / $312

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

Book by 5 Oct to save
£200 / €280 / $312

December 2018

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

Pharmacovigilance

3-5 Dec 2018

Book by 12 Oct to save
£300 / €420 / $468

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

Book by 5 Oct to save
£100 / €140 / $156

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

US Patent Practice

4-5 Dec 2018

Book by 5 Oct to save
£200 / €280 / $312

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

Book by 5 Oct to save
£100 / €140 / $156

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.

Book by 12 Oct to save
£200 / €280 / $312

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.

Book by 12 Oct to save
£200 / €280 / $312

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

Book by 5 Oct to save
£200 / €280 / $312

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.

Book by 20 Sep to save
£200 / €280 / $312

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

New course for 2018

Book by 5 Oct to save
£200 / €280 / $312

January 2019

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

February 2019

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 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

This programme highlight the different perspectives of academic parties, commercial parties and institutional funding bodies and explain some of the legal issues affecting R&D agreements.

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

Contract Law 2018 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Contract Law Update

28 Feb 2019

March 2019

This course will provide examples of common issues/pitfalls and will enable you to improve your audit report writing skills, and therefore, give you more confidence in creating effective reports via which your audit outputs can be communicated to your stakeholders.

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

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.

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

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

Book by 3 Oct to save
£200 / €280 / $312

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.

Advanced Veterinary Pharmacovigilance – the purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.

This two day course which has been designed specifically for those working in a support staff role provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development.

Practical Guidance on Borderline Issues and Combination Products

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

19-21 Mar 2019

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

This course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience

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.

Pre-Filled Syringes

20 Mar 2019

General introduction and important information on FDA Procedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

The essential conference for pharmaceutical and medical device professionals covering advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods – plus a regulatory update

Injectable Drug Delivery

21-22 Mar 2019

Pharmaceutical Regulatory Affairs in Africa including South Africa, Algeria ,Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Nigeria, Namibia, 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

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 rICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

April 2019

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 GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and CVMP.

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

Book by 31 Aug to save
£100 / €140 / $156

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.

Book by 31 Aug to save
£100 / €140 / $156

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.

Book by 17 Aug to save
£200 / €280 / $312

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 interesting new data and innovative technologies.

Nasal Drug Delivery

11-12 Apr 2019

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.

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 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.

May 2019

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

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 in both the assessments of risk and the whole CAPA and preventative action elements.

Book by 21 Sep to save
£200 / €280 / $312

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

Book by 21 Sep to save
£100 / €140 / $156

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.

The Pharma Mini MBA

13-15 May 2019

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products.

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

Book by 13 Sep to save
£100 / €140 / $156

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

Book by 5 Oct to save
£200 / €280 / $312

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.

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

Book by 19 Sep to save
£100 / €140 / $156

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

Book by 21 Sep to save
£100 / €140 / $156

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

Book by 5 Oct to save
£200 / €280 / $312

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.

Book by 21 Sep to save
£100 / €140 / $156

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

June 2019

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

Book by 11 Sep to save
£200 / €280 / $312

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

New course for 2018

Book by 8 Oct to save
£200 / €280 / $312

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

Book by 13 Sep to save
£300 / €420 / $468

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

Book by 11 Sep to save
£200 / €280 / $312

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

Book by 28 Sep to save
£100 / €140 / $156

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.

Book by 5 Oct to save
£100 / €140 / $156

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

US Patent Practice

13-14 Jun 2019

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.

Book by 5 Oct to save
£100 / €140 / $156

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 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.

Book by 31 Dec to save
£200 / €280 / $312

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

Business and Contract Law

20-21 Jun 2019

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

Book by 5 Oct to save
£200 / €280 / $312

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

Pharmacovigilance

24-26 Jun 2019

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 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

Advanced PCT Formalities

27-28 Jun 2019

Book by 5 Oct to save
£200 / €280 / $312

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

July 2019

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

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.

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.

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

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.

September 2019

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

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

This programme highlight the different perspectives of academic parties, commercial parties and institutional funding bodies and explain some of the legal issues affecting R&D agreements.

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

24-26 Sep 2019

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.

Contract Law 2018 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Contract Law Update

25 Sep 2019

This course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and 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

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

October 2019

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

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

November 2019

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.

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 is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.

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 and in-vitro diagnostic products.

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.

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

Advanced PCT Formalities

21-22 Nov 2019

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

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.

Business and Contract Law

28-29 Nov 2019

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

December 2019

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

US Patent Practice

5-6 Dec 2019