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

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

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

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

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

A three-day accelerated management programme, designed specifically for pharmaceutical/ biotechnology professionals and also applicable to medical device/animal health industries, to give you the high-performance management skills of an MBA

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

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

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

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

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

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

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

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

New for 2019

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

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

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions

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

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

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

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

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

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

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

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

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

NEW COURSE!

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

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

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

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

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

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

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

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

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

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

NEW COURSE

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

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

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

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

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

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

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

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

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

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

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

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

Practical Guidance on Borderline Issues and Combination Products

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 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

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

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

A step by step practical guide to Strategic IP Planning

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

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

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

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

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

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

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

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device

This 18th 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.

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

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

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.

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.

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 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.

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

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

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

This 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

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.

A three-day accelerated management programme, designed specifically for pharmaceutical/ biotechnology professionals and also applicable to medical device/animal health industries, to give you the high-performance management skills of an MBA

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

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

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

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions

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

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

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

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

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

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

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 European patent attorneys need to know. A 2-day highly interactive seminar

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

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

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

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

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 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 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

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

This course 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 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)

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 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 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.

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