Please visit http://www.marques.org/conferences/ for details
In these difficult times, it is still essential to keep ‘up-to-date’. This conference has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, technology and standardisation perspectives in order to improve patient safety and compliance and increase efficiency.
The package of new measures introduced by the European Patent Office, some of them referred to by the name ‘Raising the Bar’, entered into force on 1 April 2010. They encompass new rules concerning search and examination at the EPO, and time limits for the filing of divisional applications.
Pharmacokinetics and metabolism are now accepted as key disciplines in drug development providing an insight into differences in drug action within and between species. Unfortunately for many people it is also one of the more complex to understand and to put into practice, particularly with the new approaches such as in-vivo metabolism, genetic polymorphism, interaction studies, kinetic-dynamic modelling, bioavailability, population kinetics, biotechnology etc. The lecturers, who come from academia, industry and the regulatory agency, have many years’ experience in this area. They will provide information on the use and benefits of pharmacokinetics in drug development and how it affects drug discovery. Allowances have beenmade within the programme for discussion so that particular problems can be considered in detail.
This seminar will examine the experience gained in implementing the legislation to provide valuable advice to all in the animal health industry. The difficulties of authorisation of generic products will also be addressed.
The seminar will provide an opportunity to hear the views and latest experience of regulatory and industry experts in the implementation of the legislation and procedures. In addition, it will provide a valuable forum for those planning the authorisation of generic veterinary medicines to discuss the detailed requirements.
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success.
This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. The course will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company.
The purpose of this training course is to provide Non-Biotechnologists with the basic theory to understand principles, techniques and the potentials of Biotechnology.
Biotechnology combines disciplines such as Molecular Biology, Biochemistry, Chemistry, Microbiology, Chemical Engineering and Computing. This rapidly advancing science offers new and exciting opportunities to mankind, especially in the fight against disease.
WHY SHOULD YOU ATTEND?
If you have any questions regarding this seminar please email sarah.packham@management-forum.co.uk
The EPO's Patent Academy organises together with DG operations of the European Patent Office (DG1) the annual seminar for patent professionals: Examination Matters.
Are you a patent professional and would you like to exchange thoughts about patenting with an experienced EPO examiner and at the same take advantage of a fine networking opportunity with colleagues? Then sign up for the seminar. It takes place 23rd and 24th of September this year in The Hague (Netherlands) at the premises of the EPO.
If you are not able to attend, then I would be greatful if you could recommend this event to your colleague patent professionals.
15% Earlybird discount if booking made before 30 July 2010. This discount not valid with any other discount.
Overcome the practical issues of a Freedom to Operate Project by registering for this comprehensive one day seminar.
Does your biotech portfolio need to generate more revenue?
Register for this one day seminar to:
If you have any questions please contact sarah.packham@management-forum.co.uk
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval.
Medicines treat, cure or prevent illness. Foods provide nutrition. But are the distinctions so clear? Foods also have a physiological effect and a role in disease risk reduction - and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines and foods is essential for the successful marketing of specialist health products: getting it wrong is a costly route to market failure. However, the regulatory framework is detailed and complex, requiring a knowledge of the relevant legislation. By addressing these topics, this seminar aims to assist delegates to an understanding of how the borderline may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them.
Justin Shieh will be speaking at the IP Service World event in Berlin, September 27-28. He’s hosting a roundtable discussion on the 27th (“Stretching your IP Budget: cost-saving strategies for foreign filing”) and is a featured presenter in the “IT for IP in International Business” workshop on the 28th.
This course provides a comprehensive review of the FDA Combination Product process. The course provides approaches to the preparation and submission of documents to the Office of Combination Products. Delegates will receive essential guidance and information about the Combination Product process, submission preparation and the underlying scientific and regulatory principals involved.
Patent Resources Group (PRG) USA in Association with Management Forum UK Ltd
**Please register directly with PRG via the link below**
If you file patents before the EPO and the USPTO you will know that the two offices have very different approaches to application requirements.
This often results in having to draft TWO separate specifications for ONE invention, which is time-consuming, complicated and expensive.
This seminar will show you how to draft and prosecute ONE patent applications which will comply with the differing requirements of BOTH the EPC and the USPTO.
There will be practical worked examples, illustrations, demonstrations of ‘best practice’ and plenty of discussion, ensuring that you will go home with a realistic and workable solution to a perennial problem.
Instructors:
Bradley Hulbert
David Meldrum
The inventor protected anywhere and everywhere in the same way. What a beautiful dream ! At the same time, people brought together through their common interest, will feel drawn to one another, we will thus work towards a creation of peace, of concord, we will work for the benefit of humanity » (Eugène Pouillet, founding member of AIPPI). The idea of creating AIPPI, an international non-governmental organisation for the protection of intellectual property, is in line with the spirit of the universalist and philanthropic movement of the 1890’s and subsequently became a reality in 1897, at the Brussels World’s Fair. Gathering together industrialists, specialised legal practitioners and those who were called engineers-counsels, in a place of exchange and advancement of ideas, AIPPI experienced rapid success to become the largest international association in the world dedicated to the protection of intellectual property. Today, with around 9000 members, in more than 100 countries, AIPPI continues its work of reflection and harmonisation through the adoption of resolutions, and is thus an intellectual reference of the highest order and a source of inspiration for legislators. AIPPI is regularly involved with WIPO, WTO, governments, National patent and trade mark offices and regional institutions.
If you file patents before the EPO and the USPTO you will know that the two offices have very different approaches to application requirements.
This often results in having to draft TWO separate specifications for ONE invention, which is time-consuming, complicated and expensive.
Pharmacovigilance has become one of the most demanding aspects for licence holders to both understand and comply with. There are many requirements for Companies to perform various duties regarding the safety of their products to satisfy regulatory demands. Regulatory Authorities are visiting all licence holders to perform inspections on a Companies compliance to Pharmacovigilance and the visits can also include visiting marketing partners as well (even outside the EU) and the sanctions that exist for those Companies who do not look after the safety of their products are severe and could result in licence withdrawal.
As truly pan-European requirements for product development and registration have become a reality, there is an accompanying need for a consistent, homogenous and harmonised approach for the monitoring of adverse drug reactions and the sharing of safety information across the EU. The various EU Pharmacovigilance guidelines intend to achieve this. This seminar will provide an interpretation of the new regulations and detailed guidance on how SARs should be handled, the requirements of PSURs and Pharmacovigilance Inspections. This will be reinforced by interactive case-based discussions and workshops. In addition, an overview of some of the future issues in respect of global harmonisation and electronic communication will be considered.
This meeting will look at the latest guidance on how to prepare the Clinical Overview and Summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document.
Invaluable and successful annual forum where patent administrators can obtain the latest formalities information from the EPO and WIPO, together with an update on USPTO matters, and other issues of importance. Plenty of discussion time allowed.
15% Earlybird discount if booking made before 27 July 2010. This discount not valid with any other discount.
Invaluable and successful annual forum where patent administrators can obtain the latest formalities information from the EPO and WIPO, together with an update on USPTO matters, and other issues of importance. Plenty of discussion time allowed.
Previous delegates have said:
‘Very informative and a lot of content to take in but well worth the time spent’
‘Both speakers provided excellent content. Both were enthusiastic, easy to listen to – inspiring even!’
By attending this introductory level seminar you will:
For more information, please view the full brochure.
This course is independent of, yet builds upon some of the key concepts on day one (The MDD, Quality Systems and Conformity Assessment course). The important role of Technical Documentation is increasing and this course is designed to enable delegates to learn more about the new initiatives in the format and review of Technical Documentation for Medical Devices. It is relevant to all who have to compile and review such documentation.
The course is intended for manufacturers of medical devices and IVD’s and would be valuable to anyone working in either the supply chain or quality.
The course will be interactive and use case studies in most of the sessions to demonstrate the learning points.
The risk management process is the backbone of the European Regulation. As such, its effective implementation is key to the success of the manufacturer in complying with the requirements. The purpose of this training day is to present the background of risk management in the framework of the relevant harmonized standards. Through practical examples the process is rolled out, and its impact on the organisation and its documentary system is explained. The course is interactive and will involve the trainees in completing case studies.
The risk management process is the backbone of the European Regulation. As such, its effective implementation is key to the success of the manufacturer in complying with the requirements.
The purpose of this training day is to present the background of risk management in the framework of the relevant harmonised standards. Through practical examples the process is rolled out, and its impact on the organisation and its documentary system is explained. The course is interactive and will involve the trainees in completing case studies.
Good planning can maximize the benefits from publications, avoid missing important communications opportunities and increase the return on investment for clinical trials. On the other hand, poor planning can lead to delays and tension between investigators / opinion leaders and research sponsors and even damage the reputation of your company. Developing and delivering effective publication plans requires in-depth knowledge about how journals and conferences operate and keeping abreast of a wide range of rapidly moving guidelines.
This seminar will consider, drawing on case law and the speakers’ experience, the present working of opposition and appeal procedures at the European Patent Office, including recent developments.
Learn how to operate Good Distribution Standards under the guidance of the UK MHRA Healthcare Regulations by following the Orange Guide.
15% Earlybird discount if you book before 20 August 2010
Reduce risk and avoid expensive legal proceedings by attending this comprehensive one day seminar on Contract Law.
Publications in peer-reviewed journals should forma vital part of any company’s communication strategy. Several companies have recently discovered, to their cost, that inappropriate publication strategies can cause negative publicity and upset relations with investigators and editors.
Developing a responsible and effective publication strategy involves more than just understanding how journals and meetings work and how long publications will take. Publication professionals need to advise colleagues and clients about a wide range of issues including authorship, copyright and media relations as well as keeping abreast of rapidly moving guidelines and journal requirements. Despite the numerous guidelines, the publications arena is not as tightly regulated as other aspects of clinical research, so publication planners also have to understand how individual journals are interpreting and implementing the latest guidance. Managers also need to understand the implications of new legislation, such as the FDA Amendments Act. Publication departments need to demonstrate the value they bring (for in-house work) or justify their charges (for agencies). Publication managers therefore need to develop useful metrics.
Building on the Introduction to Publication Planning and on previous, successful Management Forum workshops, this intensive one-day course will equip publications professionals with a range of important information and skills.
This seminar will cover the main aspects of substantive patent law as evolved by the decisions of the EPO Boards of Appeal, including recent developments.
The ISO10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO10993 standards is the easiest way tomeet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed, or existing parts revised which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinates the full set of the existing 20 parts in the series.
A basic introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development, including consideration of:
DoverTech is an event made possible by the City of Dover and the business leaders of Dover Business and Industrial Development Authority working together to support and advance technology oriented businesses and to cultivate innovative ideas that lead to commercial ventures.
DoverTech is a one-day event that brings together sellers and buyers of intellectual property. Intellectual property in the form of patents, trademarks, and copyrights is presented to target audiences in short summaries for potential sale or license and also for further development or commercialization. DoverTech offers a real opportunity to transfer technology, build business relationships, and network with people interested in new ideas and innovations.
The demarcation betweenmedicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating amedicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals andmedical devices. This seminarwill provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.
At some point every European patent attorney will almost certainly have to appear at oral proceedings, either to defend a client's valuable invention or patent, or in an attempt to have patents held by the client's competitors revoked or limited in scope.
In order to defend a client's interests competently, it is vital to be properly prepared, and to know what to expect at this European level.
Through the use of teaching sessions and practical workshops, including rôle-play and simulated hearings, the course will work through the practical steps needed to deal with preparing for and appearing at oral proceedings.
The course has been prepared for qualified European Patent attorneys and for trainees preparing to qualify, who have a working knowledge of the European Patent Convention and know how to prosecute an application through the written procedure.
Obtaining the right scientific advice at the right time can make or break a drug development programme, and companies are willing to invest considerable time & resources in managing scientific advice procedures. It is now seen as being essential rather than optional to obtain input from the regulatory authorities at key stages of development.
This seminar will examine the routes available for obtaining scientific advice in Europe, provide insight as to how to manage these procedures effectively and discuss how to incorporate scientific advice into development programmes. Additionally an overview of the new NICE Scientific Advice Consultancy Service will be provided.
This seminar will consider, drawing on case law and the speakers’ experience, the present working of opposition and appeal procedures at the European Patent Office, including recent developments.
Together with PATENTS – THE EPO CASE LAW on the following day, it offers a summary of both background and recent developments from the perspective of speakers with day to day involvement in the practice and procedure of EPO oppositions and appeals.
At some point every European patent attorney will almost certainly have to appear at oral proceedings, either to defend a client's valuable invention or patent, or in an attempt to have patents held by the client's competitors revoked or limited in scope.
This seminar will cover the main aspects of substantive patent law as evolved by the decisions of the EPO Boards of Appeal, including recent developments.
Together with OPPOSITIONS AND APPEALS – THE EPO CASE LAW on the previous day, it offers a summary of both background and recent developments from the perspective of speakers with day to day involvement in the practice and procedure of EPO oppositions and appeals.
Do you need to understand when and how to protect your confidential information?
Sign up for this one day training session to:
If you have any questions in relation to this training day please contact sarah.packham@management-forum.co.uk
Part of our new legal training day series, Introduction to Intellectual Property offers an excellent overview for those new to IP.
If you have any questions in relation to this training day please contact sarah.packham@management-forum.co.uk
Previous delegates have said:
‘Very informative and a lot of content to take in but well worth the time spent’
‘Both speakers provided excellent content. Both were enthusiastic, easy to listen to – inspiring even!’
By attending this introductory level seminar you will:
To book your place on this important event, please click here.
Designed with SME customers in mind, this one day session forms part of our new series of legal training days.
Attendees will benefit by -
If you have any questions in relation to this training day please contact sarah.packham@management-forum.co.uk
Do you need to understand when and how to protect your confidential information?
Sign up for this one day training session to:
If you have any questions in relation to this training day please contact sarah.packham@management-forum.co.uk
Paper C is the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper, and will enable them to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
The course is designed for first-time and re-sitting candidates for Paper C, and is in the form of a workshop, with practice papers and extensive discussions between the participants and the speaker.
Paper C is the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper, and will enable them to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
The course is designed for first-time and re-sitting candidates for Paper C, and is in the form of a workshop, with practice papers and extensive discussions between the participants and the speaker.
15% Earlybird discount if booking made before 27 August 2010. This discount not valid with any other discount.
Improve your drafting and negotiation skills by attending this specifically designed seminar which tackles the issues that can arise when handling clinical trial agreements (CTAs).
This intensive three day course covers the key areas of an MBA and applies these MBA tools and concepts to the Bio/ Pharmaceutical industry, providing you with a firm foundation of the essential MBA thinking and terminology. Three modules will be covered in just threedays of workshops minimising disruption to your normal work. To enhance the value of the course and minimise your time away from the office there is also optional pre and post-work set by the tutors (at no extra cost).
15% early bird discount for registrations received before the 24th September
Are you involved with the drafting of International IP Agreements?
Register for this comprehensive one day seminar to:
Delegates that have attended this seminar previously, have said:
‘[The tutor is] very knowledgeable, and obviously highly experienced. The examples used were very helpful for me’.
‘A lot of information is covered but a comprehensive pack is supplied’.
This seminar provides a detailed introduction to the European medical device legislation. It will explain the directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do, plus the documentation necessary to apply for the CE Mark. This is an excellent introduction from leading experts in the field and delegates should expect two comprehensive days of training.
This popular event is also taking place in London on 22-23rd November.
If you file patents before the EPO and the USPTO you will know that the two offices have very different approaches to application requirements.
An application originating in Europe frequently encounters substantial difficulties before the USPTO. The European applicant often faces rejections based on alleged inadequacies in the specification. Recurrently, claims issued to a European applicant are unnecessarily narrow by US standards or unexpectedly constrained by US principles of disavowal, disclaimer and estoppel.
This often results in having to draft TWO separate specifications for ONE invention, which is time-consuming, complicated and expensive.
This seminar will show you how to draft and prosecute ONE patent applications which will comply with the differing requirements of BOTH the EPC and the USPTO.
There will be practical worked examples, illustrations, demonstrations of ‘best practice’ and plenty of discussion, ensuring that you will go home with a realistic and workable solution to a perennial problem.
If you file patents before the EPO and the USPTO you will know that the two offices have very different approaches to application requirements.
This popular event is also taking place in Munich on 18th-19th November.
If you file patents before the EPO and the USPTO you will know that the two offices have very different approaches to application requirements.
An application originating in Europe frequently encounters substantial difficulties before the USPTO. The European applicant often faces rejections based on alleged inadequacies in the specification. Recurrently, claims issued to a European applicant are unnecessarily narrow by US standards or unexpectedly constrained by US principles of disavowal, disclaimer and estoppel.
This often results in having to draft TWO separate specifications for ONE invention, which is time-consuming, complicated and expensive.
This seminar will show you how to draft and prosecute ONE patent applications which will comply with the differing requirements of BOTH the EPC and the USPTO.
There will be practical worked examples, illustrations, demonstrations of ‘best practice’ and plenty of discussion, ensuring that you will go home with a realistic and workable solution to a perennial problem.
In these sessions we will discuss what we can and should learn about pharmacokinetics and pharmacodynamics in the early clinical evaluation of drugs in development. Examples of how pharmacodynamic measures can be used as biomarkers and surrogates of efficacy and safety will be presented. The application of this information to assess benefit:risk and design dosing regimens in subsequent clinical trials will be demonstrated.
If you file patents before the EPO and the USPTO you will know that the two offices have very different approaches to application requirements.
The first presentation will focus on Drug Switchability, in particular the application of Bioavailability, Bioequivalence and Biosimilarity to small and large molecule drugs, across the entire development process, including post-marketing studies and Generics. The second presentation covers key aspects of the role of population PK and PK/PD in drug development.
Part of our new legal training day series, Introduction to Intellectual Property offers an excellent overview for those new to IP.
If you have any questions in relation to this training day please contact sarah.packham@management-forum.co.uk
The presentations will provide information on the use of preclinical pharmacokinetic data in drug discovery and drug development and how these are applied in the assessment and prediction of potential human efficacy and safety. The talks will consider aspects of physicochemistry in drug design as well as the regulatory requirements and expectations for preclinical pharmacokinetics. There is sufficient flexibility within the programme to provide opportunity for discussion such that particular issues may be considered in detail.
Designed with SME customers in mind, this one day session forms part of our new series of legal training days.
Attendees will benefit by -
If you have any questions in relation to this training day please contact sarah.packham@management-forum.co.uk
Rather than simply testing preparation of EQE candidates, this revision course aims to propose a structured approach to successfully tackle paper D.
It will involve teaching, discussion and practical exercises involving recent DII papers.
Delegates will be
Rather than simply testing preparation of EQE candidates, this revision course aims to propose a structured approach to successfully tackle paper D.
It will involve teaching, discussion and practical exercises involving recent DII papers.
Please visit http://www.njipla.org/events.asp for further information
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