A comprehensive overview of MDIs including development, manufacture, regulation and market potential
20-21 Feb 2019
This one hour webinar will help you understand what has the impact of GDPR been on drug development
25 February 2019 – 2pm (GMT)
Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day
A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements
27-28 Feb 2019
Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English Law
Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment
6-7 Mar 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
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.
6-7 Mar 2019
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!
A two-day no-nonsense plain English practical course to get-to-grips with business and contract law for busy business executives.
7-8 Mar 2019
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.
11 Mar 2019
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.
12-13 Mar 2019
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.
13-14 Mar 2019
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.
14-15 Mar 2019
Practical Guidance on Borderline Issues and Combination Products
14-15 Mar 2019
This two-day course will challenge your current thinking and behaviour in all areas of communication.
14-15 Mar 2019
Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!
A step by step practical guide to Strategic IP Planning
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 (CTD)
This course provides an essential overview and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience
20-21 Mar 2019
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
21-22 Mar 2019
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe
25-26 Mar 2019
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
25-27 Mar 2019
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
25-26 Mar 2019
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.
27 Mar 2019
Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.
28-29 Mar 2019
Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures
28 Mar 2019
Book by 18 Feb to save
£100 / €140 / $156
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
Book by 18 Feb to save
£100 / €140 / $156
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Book by 18 Feb 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
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
Understand the importance of accuracy and attention to detail in day-to-day work
Book by 1 Mar to save
£100 / €140 / $156
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
4-5 Apr 2019
Communicate, influence and motivate to enhance internal and external relationships and to help improve both yours and the business performance.
5 Apr 2019
Book by 1 Mar 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
8-9 Apr 2019
Book by 18 Feb to save
£200 / €280 / $312
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
9-10 Apr 2019
Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology.
10-12 Apr 2019
This conference gives a comprehensive review within the field of nasal drug delivery while reviewing the very latest new data and innovative technologies.
11-12 Apr 2019
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
11-12 Apr 2019
Book by 18 Feb to save
£200 / €280 / $312
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
24-26 Apr 2019
Book by 15 Mar to save
£300 / €420 / $468
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.
29-30 Apr 2019
Book by 15 Mar to save
£200 / €280 / $312
An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management
Book by 22 Mar to save
£200 / €280 / $312
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.
Book by 26 Mar 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 26 Mar to save
£100 / €140 / $156
Understand the impact of IP on pharmaceutical regulatory strategy
Book by 15 Mar to save
£100 / €140 / $156
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.
Book by 15 Mar to save
£200 / €280 / $312
This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits
9-10 May 2019
Book by 15 Mar to save
£200 / €280 / $312
This two-day workshop is for those new to negotiations or for those who wish to refresh and/or enhance their existing negotiation skills.
9-10 May 2019
Book by 5 Apr to save
£200 / €280 / $312
Aquire key skills in maximising success in an expanding herbal product market
10 May 2019
Book by 15 Mar to save
£100 / €140 / $156
Gatherine and using clincal evidence for CE marking and post-market compliance in line with the new MDR
13-14 May 2019
Book by 22 Mar to save
£200 / €280 / $312
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
14-16 May 2019
Book by 15 Mar to save
£300 / €420 / $468
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 10 Apr to save
£100 / €140 / $156
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
15-16 May 2019
Book by 5 Mar 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.
15-16 May 2019
Book by 26 Mar to save
£200 / €280 / $312
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.
15-17 May 2019
Book by 22 Mar to save
£300 / €420 / $468
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.
Book by 5 Mar to save
£200 / €280 / $312
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.
Book by 5 Mar 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 12 Apr 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.
21-22 May 2019
Book by 22 Mar to save
£200 / €280 / $312
The ‘how to’ of technology transfer across the product lifecycle
New for 2018
21-22 May 2019
Book by 9 Apr 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.
21-23 May 2019
Book by 12 Apr to save
£300 / €420 / $468
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 12 Apr 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
22-23 May 2019
Book by 26 Mar 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
23-24 May 2019
Book by 12 Apr to save
£200 / €280 / $312
A two-day course that will ensure you to comply with new regulatory requirements
23-24 May 2019
Book by 12 Apr to save
£200 / €280 / $312
This practical four day course provides a comprehensive understanding of a veterinary medicine development in the EU and USA.
Book by 26 Mar to save
£400 / €560 / $624
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
Book by 9 Apr 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
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 10 Apr to save
£300 / €420 / $468
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
5-6 Jun 2019
Book by 26 Mar to save
£200 / €280 / $312
Proactively manage the legal and commercial considerations essential for securing a successful international agreement
Book by 9 Apr to save
£200 / €280 / $312
This course will give you a comprehensive introduction to the role of the Patent Administrator
7 Jun 2019
Book by 26 Apr to save
£100 / €140 / $156
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
NEW COURSE!
12-13 Jun 2019
Book by 10 May 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 26 Apr to save
£100 / €140 / $156
US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar
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.
13 Jun 2019
Book by 26 Apr 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.
17-18 Jun 2019
Book by 10 May to save
£200 / €280 / $312
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
18-20 Jun 2019
Book by 9 Apr to save
£300 / €420 / $468
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.
19 Jun 2019
Book by 17 May to save
£100 / €140 / $156
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 3 May to save
£200 / €280 / $312
Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.
19-20 Jun 2019
Book by 9 Apr 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.
20-21 Jun 2019
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
Book by 26 Apr to save
£100 / €140 / $156
A two-day seminar for Administrative Staff in the Patent Profession on how to competently prepare an application for filing before the EPO
20-21 Jun 2019
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in Drug safety.
24-26 Jun 2019
Book by 10 May to save
£300 / €420 / $468
A two-day course for those looking to improve their decision-making and problem-solving skills within the pharma industry
NEW COURSE!
24-25 Jun 2019
Book by 20 May to save
£200 / €280 / $312
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
27 Jun 2019
Book by 10 May to save
£100 / €140 / $156
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 10 May to save
£100 / €140 / $156
This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills
1-2 Jul 2019
Book by 10 May to save
£200 / €280 / $312
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.
Book by 3 May to save
£500 / €700 / $780
Understand RMPs relationship to safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance
Book by 10 May 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.
3-4 Jul 2019
Book by 8 May 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.
3-4 Jul 2019
Book by 8 May to save
£200 / €280 / $312
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.
Book by 10 May to save
£100 / €140 / $156
A concise one-day seminar about the key principles of delegation, its link to motivation and impact on productivity.
5 Jul 2019
Book by 31 May to save
£100 / €140 / $156
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.
8-9 Jul 2019
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
16 Sep 2019
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.
17-18 Sep 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
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
18-19 Sep 2019
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
19-20 Sep 2019
Practical Guidance on Borderline Issues and Combination Products
19-20 Sep 2019
Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
23-24 Sep 2019
Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures
23 Sep 2019
A step by step practical guide to 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.
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.
24-25 Sep 2019
Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission
24 Sep 2019
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
25-26 Sep 2019
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
25-27 Sep 2019
Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology.
25-27 Sep 2019
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 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.
26-27 Sep 2019
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.
27 Sep 2019
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
30 Sep 2019
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
1 Oct 2019
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
2-3 Oct 2019
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
3-4 Oct 2019
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
7-8 Oct 2019
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
8-9 Oct 2019
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Understanding connected medical devices, medical mobile Apps and the Medical Device Internet of Things
9-10 Oct 2019
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.
10 Oct 2019
This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.
11 Oct 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.
14-16 Oct 2019
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
16-17 Oct 2019
Interactive course ideal for anyone with responsibility for planning or delivering training in the Pharma, Device or Animal Health Industries (including GXP and SOP training to comply with EU and FDA inspection requirements).
There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.
21-22 Oct 2019
This programme will give you an invaluable overview of the Pharmaceutical industry, from discovery of the molecule through development to marketing
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
23-24 Oct 2019
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
30-31 Oct 2019
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
30-31 Oct 2019
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.
31 Oct-1 Nov 2019
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
4-6 Nov 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.
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.
5-6 Nov 2019
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
6-7 Nov 2019
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.
7-8 Nov 2019
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.
7 Nov 2019
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.
11-13 Nov 2019
This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits
11-12 Nov 2019
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
NEW COURSE!
13-14 Nov 2019
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements
Gatherine and using clincal evidence for CE marking and post-market compliance in line with the new MDR
14-15 Nov 2019
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
14-15 Nov 2019
Creating a team that speaks and acts with one vision in the pharma/device/animal health industries
18-19 Nov 2019
Understand the impact of IP on pharmaceutical regulatory strategy
This course will give you a comprehensive introduction to the role of the Patent Administrator
19 Nov 2019
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
19-20 Nov 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.
19-20 Nov 2019
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
19-20 Nov 2019
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong Macau and Taiwan.
20-21 Nov 2019
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
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
25-26 Nov 2019
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
26-27 Nov 2019
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.
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
28-29 Nov 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
2 Dec 2019
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in Drug safety.
2-4 Dec 2019
This meeting will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA
Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.
4-5 Dec 2019
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.
4-5 Dec 2019
US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar
5-6 Dec 2019
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
9-10 Dec 2019
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!
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.
11-12 Dec 2019
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.
30-31 Jan 2020