Calendar

November 2017

This one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.

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

Pharmaceutical Regulatory Affairs in Latin America a comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin Americal countries

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

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

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

30 Nov-1 Dec 2017

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).

December 2017

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

Pharmacovigilance

4-6 Dec 2017

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

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

This course explores what is meant by ‘assertive behaviour’. It will provide you with an opportunity to practice skills and techniques to help you to become more assertive and more efficient in your dealings with clients and colleagues.

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

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

This meeting will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA

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

January 2018

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.

Book by 15 Dec to save
£200 / €280 / $312

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

Book by 15 Dec to save
£100 / €140 / $156

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

Book by 22 Dec to save
£200 / €280 / $312

The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities.

Book by 15 Dec to save
£100 / €140 / $156

An insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS.

Book by 15 Dec to save
£100 / €140 / $156

February 2018

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

Book by 18 Dec to save
£200 / €280 / $312

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.

Book by 18 Dec 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 18 Dec to save
£200 / €280 / $312

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.

Book by 18 Dec to save
£100 / €140 / $156

Contract Law 2017 – 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

Book by 18 Dec to save
£100 / €140 / $156

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

Book by 22 Dec to save
£200 / €280 / $312

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

Book by 12 Jan to save
£100 / €140 / $156

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 role.

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

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

Book by 12 Jan to save
£100 / €140 / $156

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.

Book by 22 Dec to save
£200 / €280 / $312

This seminar will enable you to meet the new international GCP ICH GCP E6 standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union, Japan, the United States, Canada and Switzerland.

Book by 12 Jan to save
£100 / €140 / $156

This one-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

Book by 22 Dec to save
£100 / €140 / $156

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

Book by 12 Jan to save
£100 / €140 / $156

March 2018

This interactive meeting will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation, which came into force in 2016.

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

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

Book by 18 Dec to save
£200 / €280 / $312

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 12 Jan to save
£200 / €280 / $312

This course will be of maximum benefit to those 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

Book by 18 Dec to save
£100 / €140 / $156

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

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

19-20 Mar 2018

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

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

20-22 Mar 2018

Book by 18 Dec to save
£300 / €420 / $468

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.

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.

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

21 Mar 2018

Book by 12 Jan to save
£100 / €140 / $156

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

22-23 Mar 2018

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

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.

Book by 12 Jan to save
£100 / €140 / $156

April 2018

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

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

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

Nasal Drug Delivery

12-13 Apr 2018

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

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 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.

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.

Practical Guidance on Borderline Issues and Combination Products practical guidance on Borderline issues and combination products

Understand the licensing of veterinary vaccines by USDA and CFIA, understand the phased submission process for vaccine licensing, and learn the format and content specifications for the required dossier components.

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

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

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

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

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.

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

May 2018

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

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.

A basic In-house 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 one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.

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

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

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.

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 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

14-16 May 2018

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

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.

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

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

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

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.

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

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

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

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

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

June 2018

A practical five day In-house course Working through Veterinary Drug Development in the EU and the USA

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).

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

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

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

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

US Patent Practice

13-14 Jun 2018

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 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

14-15 Jun 2018

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

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

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

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

Pharmacovigilance

19-21 Jun 2018

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.

Dry Powder Inhalers, Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

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

A one-day programme which looks at the basic principles of Pharmacoepidemiology together with their practical application

Pharmacoepidemiology

22 Jun 2018

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

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 2018

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

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

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.

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

The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities.

An insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS.

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 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 2017 – 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

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 provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support role.

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 course will be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing

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 seminar will enable you to meet the new international GCP ICH GCP E6 standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union, Japan, the United States, Canada and Switzerland.

October 2018

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 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.

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

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

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

Book by 18 Dec to save
£200 / €280 / $312

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.

Book by 18 Dec to save
£100 / €140 / $156

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

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

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

This 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

Understand the licensing of veterinary vaccines by USDA and CFIA, understand the phased submission process for vaccine licensing, and learn the format and content specifications for the required dossier components.

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

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

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

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.

November 2018

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

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

A basic In-house 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.

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

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

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

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

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

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.

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).

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

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

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

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

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

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

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

December 2018

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

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

US Patent Practice

4-5 Dec 2018

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

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

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

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