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Wed, Nov 11, 2009		3rd Annual Stability Testing Conference - Conference (BSG House, London, UK) Well planned, executed and managed stability studies are critical for understanding data generated during clinical trials. Stability testing is an expensive part of product development, but conducted efficiently, it can save money in latter parts of the lifecycle. Visiongain's 3rd Annual Stability Testing conference will examine developments in technology for stability assessment. As part of this 2-day event, leading authorities will assess the application and limitations of various analytical and statistical methods, as well as study design. Participants will be provided with a reliable evaluation of the principles and techniques associated with the stability testing of biologics and new pharmaceutical products.
Wed, Nov 11, 2009		Pre-Conference Seminar QbD IN INHALATION PRODUCT DEVELOPMENT - Course / Training / Workshop (The Cavendish Hotel, London) Full Details will follow shortly. Please contact andrea.james@management-forum.co.uk for further information or a brochure.
Thu, Nov 12, 2009		3rd Annual Stability Testing Conference - Conference (BSG House, London, UK) Well planned, executed and managed stability studies are critical for understanding data generated during clinical trials. Stability testing is an expensive part of product development, but conducted efficiently, it can save money in latter parts of the lifecycle. Visiongain's 3rd Annual Stability Testing conference will examine developments in technology for stability assessment. As part of this 2-day event, leading authorities will assess the application and limitations of various analytical and statistical methods, as well as study design. Participants will be provided with a reliable evaluation of the principles and techniques associated with the stability testing of biologics and new pharmaceutical products.
Mon, Nov 16, 2009		SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Seminar (The Rembrandt Hotel, London) 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.
Mon, Nov 16, 2009		SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Course / Training / Workshop (Hotel to be advised, London) This seminar will examine the routes available for obtaining scientific advice in Europe (including covering the recent changes to the CPMP and MHRA procedures), as well as in the US and Japan, and will explore the means of securing the best possible input and integrating advice from several different sources into a single global development programme.
Tue, Nov 17, 2009		SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Course / Training / Workshop (Hotel to be advised, London) This seminar will examine the routes available for obtaining scientific advice in Europe (including covering the recent changes to the CPMP and MHRA procedures), as well as in the US and Japan, and will explore the means of securing the best possible input and integrating advice from several different sources into a single global development programme.
Tue, Nov 17, 2009		LATEST DEVELOPMENTS IN PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) If you work in Drug Safety, this advanced course has been specifically designed to provide you with an update on the latest developments impacting on your role. The programme will include discussion and interpretation of the most current EU legislation as well as covering topical current issues relevant to Pharmacovigilance. There will be ample opportunity throughout the two days for discussion, tips and practical advice from the expert speakers and you will also be welcome to contribute your own experiences.
Wed, Nov 18, 2009		LATEST DEVELOPMENTS IN PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) If you work in Drug Safety, this advanced course has been specifically designed to provide you with an update on the latest developments impacting on your role. The programme will include discussion and interpretation of the most current EU legislation as well as covering topical current issues relevant to Pharmacovigilance. There will be ample opportunity throughout the two days for discussion, tips and practical advice from the expert speakers and you will also be welcome to contribute your own experiences.
Wed, Nov 18, 2009 9:00am		REGULATORY BASICS by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110) This course is designed for pharmaceutical and biotech professionals responsible for regulatory strategy and operations. It will teach the essentials of regulatory project management, with a focus on how these skills can be applied in the process of creating an initial Investigational New Drug (IND) application. Through the use of lectures, discussions and case studies, participants will learn about the key elements of the regulatory process in the United States, discuss the required elements of an IND, the utility of the Clinical Trials Directive (CTD) for building a foundation for continued development and other key topics. Who will benefit: This course will be beneficial to those new to regulatory affairs as well as those with regulatory experience but limited exposure to the early phases of development stage work in the pharmaceutical and biotech industries. Managers who are not versed in regulatory, but are involved with clinical trial programs will also benefit. Key topics: * What is an IND? * The Pre-IND Meeting - Dos and Don'ts * What is FDA looking for in the initial application * Is the CTD an option? * Timeline management * Submission and post submission success Learning Outcomes: * Understanding of the IND process and key decision points * Understanding of how regulatory strategy drives decisions in the drug development process * Recognition of regulatory hurdles * Knowledge of how to build effective submissions * Recognition of the need to effectively manage expectations and timelines For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Thu, Nov 19, 2009		European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009		European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Mon, Nov 23, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Tue, Nov 24, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Wed, Nov 25, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Thu, Nov 26, 2009		MEDICAL DEVICE REGULATORY AFFAIRS IN THE MIDDLE EAST - Seminar (The Rembrandt Hotel, London) BENEFITS OF ATTENDING THIS MEETING: ■ Stay Ahead of your Competitors by Understanding the Regulatory Requirements and Market Opportunities in this Region ■ Understand the Regulatory Pathways to Medical Device Markets in Israel ■ Discuss the Regulatory Developments in Saudi Arabia and the Gulf States ■ Clarify the Requirements for Medical Devices in Iran ■ Discover the Regulatory Requirements and How to Get Medical Devices on to the Jordanian Market ■ Know How to Gain Access to the Lebanese Market
Thu, Nov 26, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Fri, Nov 27, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Fri, Nov 27, 2009		INTRODUCTORY OVERVIEW OF THE PHARMACEUTICAL INDUSTRY - Course / Training / Workshop (The Rembrandt Hotel, London) Key benefits of attending this meeting:- Increase your understanding of the Pharma Industry, Develop your knowledge of the stages of drug development from drug discovery through to marketing, Understand the roles and responsibilities of key departments and how they work together, Demystify the technical terminology and jargon, Get to grips with the phases of Clinical Trials and regulatory processes.
Mon, Nov 30, 2009		MEDICAL DEVICE REGULATION IN ASIA PACIFIC - Conference (The Rembrandt Hotel, London) Overview This seminar will provide a comprehensive overview of the medical device regulations and developments in China, Japan and India together with other newly regulated countries within this geographic region. Take away practical guidance on how to comply with the requirements and gain access to these growing markets. Learn how these requirements are being interpreted and applied and how legislation may change in the future.
Tue, Dec 1, 2009		MEDICAL DEVICE REGULATION IN ASIA PACIFIC - Conference (The Rembrandt Hotel, London) Overview This seminar will provide a comprehensive overview of the medical device regulations and developments in China, Japan and India together with other newly regulated countries within this geographic region. Take away practical guidance on how to comply with the requirements and gain access to these growing markets. Learn how these requirements are being interpreted and applied and how legislation may change in the future.
Thu, Dec 3, 2009		Dermatological Advances 2009 Conference - Conference (BSG House, London, UK) Dermatology is one of the most promising sectors within the global pharmaceutical market. It has witnessed remarkable sales revenues of over $18bn in 2007, and will expand significantly in the next 10 years. Skin infections and disorders such as acne, psoriasis and dermatitis remain major revenue generators for the pharmaceutical and biotech companies. The dermatology market will regain 3.5% growth by 2010, with the development of anti-psoriasis, acne and dermatitis products and treatments (Source: visiongain). Our conference will focus on the advances and innovations in novel drug delivery, therapeutic skin treatments and anti-ageing products, primarily in the developing countries.
Thu, Dec 3, 2009		RISK MANAGEMENT - Applying it and meeting the Challenges for Industry - Course / Training / Workshop (Harrington Hall Hotel, London) INTRODUCTION Risk management is a complex operation involving the identification of risk, the assessment of that risk against a target and subsequent reduction or mitigation of the risk to bring it into the realms of acceptability. Within the Pharmaceutical / Biopharmaceutical industry we work with pharmaceutically active materials which are often potentially hazardous to both the patient and to our production operators. As an industry we need to take a holistic approach to controlling these risks. We manage the risks so that we can in a timely manner bring safe, effective medicines to the patient and at the same time do not expose our operators and support staff to health hazards. We need to take a lifecycle approach to risk management from product development through commercial supply. In doing so it is necessary to recognise that whilst the hazard is fixed, the risk can vary. A number of standard tools are available for risk management. Which ones should you use and when? ICH Q9 has recently been incorporated into the GMP for EU, Japan and USA. It is stated to be non-mandatory, but what does this mean in practice. What changes has ICH Q9 brought about for you / your company / your dealings with the regulators? WHO SHOULD ATTEND This seminar will be of particular interest to all personnel who are or will become involved in any of the following pharmaceutical manufacturing activities: ■ Manufacture or QA of API or drug product ■ Manufacturing rationalisation ■ Site transfer for API and / or drug product ■ GMP compliance ■ Management of regulatory QA / manufacturing QA interfaces ■ Design and construction of manufacturing facilities / processes ■ Validation / Cleaning validation ■ Auditing of own company or supplier Personnel from the following backgrounds: ■ Production ■ Quality Assurance ■ Engineering ■ Regulatory Affairs Compliance ■ Project Planners
Thu, Dec 3, 2009 9:00am		ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110) This course is designed for pharmaceutical and biotech professionals responsible for managing projects. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical trials are run while at the same time minimizing risk. Who will benefit: This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit. Key topics: * Achievement of corporate goals * Design of clinical trials * Project management resourcing * Risk mitigation * Identification of best practices * Process improvement * Investigator site metrics * Study enrollment * International sites * Institutional Review Board (IRB) Characteristics Learning outcomes: * Understanding the need for risk assessment * Consideration of strategic decisions in project management * Comprehension of trial design decisions * Understanding of how and why to determine best practices * Awareness of why resource planning is critical to project success * Recognition of the importance of teamwork * Strategies for improving site selection and patient recruitment For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Fri, Dec 4, 2009		Dermatological Advances 2009 Conference - Conference (BSG House, London, UK) Dermatology is one of the most promising sectors within the global pharmaceutical market. It has witnessed remarkable sales revenues of over $18bn in 2007, and will expand significantly in the next 10 years. Skin infections and disorders such as acne, psoriasis and dermatitis remain major revenue generators for the pharmaceutical and biotech companies. The dermatology market will regain 3.5% growth by 2010, with the development of anti-psoriasis, acne and dermatitis products and treatments (Source: visiongain). Our conference will focus on the advances and innovations in novel drug delivery, therapeutic skin treatments and anti-ageing products, primarily in the developing countries.
Fri, Dec 4, 2009		RISK MANAGEMENT - Applying it and meeting the Challenges for Industry - Course / Training / Workshop (Harrington Hall Hotel, London) INTRODUCTION Risk management is a complex operation involving the identification of risk, the assessment of that risk against a target and subsequent reduction or mitigation of the risk to bring it into the realms of acceptability. Within the Pharmaceutical / Biopharmaceutical industry we work with pharmaceutically active materials which are often potentially hazardous to both the patient and to our production operators. As an industry we need to take a holistic approach to controlling these risks. We manage the risks so that we can in a timely manner bring safe, effective medicines to the patient and at the same time do not expose our operators and support staff to health hazards. We need to take a lifecycle approach to risk management from product development through commercial supply. In doing so it is necessary to recognise that whilst the hazard is fixed, the risk can vary. A number of standard tools are available for risk management. Which ones should you use and when? ICH Q9 has recently been incorporated into the GMP for EU, Japan and USA. It is stated to be non-mandatory, but what does this mean in practice. What changes has ICH Q9 brought about for you / your company / your dealings with the regulators? WHO SHOULD ATTEND This seminar will be of particular interest to all personnel who are or will become involved in any of the following pharmaceutical manufacturing activities: ■ Manufacture or QA of API or drug product ■ Manufacturing rationalisation ■ Site transfer for API and / or drug product ■ GMP compliance ■ Management of regulatory QA / manufacturing QA interfaces ■ Design and construction of manufacturing facilities / processes ■ Validation / Cleaning validation ■ Auditing of own company or supplier Personnel from the following backgrounds: ■ Production ■ Quality Assurance ■ Engineering ■ Regulatory Affairs Compliance ■ Project Planners
Fri, Dec 4, 2009 9:00am		ADVANCED CLINICAL PROJECT MANAGEMENT - 2-Day workshop by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110) This course is designed for pharmaceutical and biotech professionals responsible for managing projects. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical trials are run while at the same time minimizing risk. Who will benefit: This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit. Key topics: * Achievement of corporate goals * Design of clinical trials * Project management resourcing * Risk mitigation * Identification of best practices * Process improvement * Investigator site metrics * Study enrollment * International sites * Institutional Review Board (IRB) Characteristics Learning outcomes: * Understanding the need for risk assessment * Consideration of strategic decisions in project management * Comprehension of trial design decisions * Understanding of how and why to determine best practices * Awareness of why resource planning is critical to project success * Recognition of the importance of teamwork * Strategies for improving site selection and patient recruitment For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Mon, Dec 7, 2009		Vaccine Technology 2009 Conference - Conference (BSG House, London, UK) With more targets, more investment and more oppportunity than ever, vaccine technology is among the most dynamic in biomedicine today. Advances in reverse vaccinology, computer-aided biotechnology and disposable technologies are revolutionising R&D for infectious disease, paediatric and cancer therapies. Allied with new developments in formualtion, informatics and process development, the market will see growth of over 300% between 2009 and 2023.
Mon, Dec 7, 2009		Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009		Vaccine Technology 2009 Conference - Conference (BSG House, London, UK) With more targets, more investment and more oppportunity than ever, vaccine technology is among the most dynamic in biomedicine today. Advances in reverse vaccinology, computer-aided biotechnology and disposable technologies are revolutionising R&D for infectious disease, paediatric and cancer therapies. Allied with new developments in formualtion, informatics and process development, the market will see growth of over 300% between 2009 and 2023.
Tue, Dec 8, 2009		Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Mon, Dec 14, 2009		Software Development for Medical Device Professionals - Course / Training / Workshop (Malvern, PA)
Mon, Dec 14, 2009		PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Tue, Dec 15, 2009		Software Development for Medical Device Professionals - Course / Training / Workshop (Malvern, PA)
Tue, Dec 15, 2009		PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Wed, Dec 16, 2009		PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Mon, Jan 11, 2010		Advancing Biologics from the lab to the clinic - Conference (Brussels, Belgium) This event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies .
Tue, Jan 12, 2010		Advancing Biologics from the lab to the clinic - Conference (Brussels, Belgium) This event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies .
Tue, Jan 19, 2010		PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA INCLUDING INDIA - Course / Training / Workshop (The Rembrandt Hotel, London) This seminar will focus on R&D based pharmaceutical products in Asia and will provide you with: A carefully balanced programme, Up-to-date coverage, All important aspects of gaining and maintaining a successful Marketing Authorisation in Asia, Coverage of underlying official regulatory sources, An interpretation of practical aspects, An overview of the requirements for local manufacturing, Recent Developments, Harmonisation Initiatives, The opportunity to exchange experiences with other delegates
Wed, Jan 20, 2010		PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA INCLUDING INDIA - Course / Training / Workshop (The Rembrandt Hotel, London) This seminar will focus on R&D based pharmaceutical products in Asia and will provide you with: A carefully balanced programme, Up-to-date coverage, All important aspects of gaining and maintaining a successful Marketing Authorisation in Asia, Coverage of underlying official regulatory sources, An interpretation of practical aspects, An overview of the requirements for local manufacturing, Recent Developments, Harmonisation Initiatives, The opportunity to exchange experiences with other delegates
Wed, Jan 20, 2010		EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London) WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Thu, Jan 21, 2010		EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London) WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Fri, Jan 22, 2010		ACTIVE COMPARATOR STUDIES - Course / Training / Workshop (The Rembrandt Hotel, London) Active comparator trials can fulfil a number of needs from pivotal marketing approval studies, through label enhancements of an already marketed drug to post-marketing market support. The designs of such studies have their own special issues: superiority vs non-inferiority designs, choice of comparator, two arm or three arm placebo designs amongst many others. This course aims to discuss the theoretical, operational, regulatory and statistical issues involved, using practical examples to encourage interactive discussion to share possible approaches to the design and implementation of active comparator trials. Topics to be covered at this meeting: ■ Purposes of active comparator trials ■ Design for studies ■ Statistical considerations ■ Regulatory documentation & safety monitoring ■ Safety data collection & reporting ■ Post-marketing comparator observational studies WHO SHOULD ATTEND This new course will be of interest to personnel from departments of both pre- and post-marketing pharmacovigilance, research and development, clinical trials, regulatory affairs, project management, and statistics and any others involved in designing development plans involving possible active comparator trials.
Mon, Feb 1, 2010		WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London) The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Tue, Feb 2, 2010		ANNUAL CONFERENCE ON INTERNATIONAL SPORTS LAW - A Year in Sports Law - Seminar (Institute of Directors, London ) This conference will consider and discuss the key issues in sport and in particular sports law from the last 12 months. Each major sport will be reviewed by a panel of experts and key decision makers from that sport following a short presentation on the key developments from the preceding 12 months. Chairman: Richard Verow Head of Legal, Sky Sports.
Tue, Feb 2, 2010		WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London) The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Wed, Feb 3, 2010		WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London) The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Thu, Feb 4, 2010		WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London) The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Fri, Feb 5, 2010		WORKING THROUGH DRUG DEVELOPMENT - Winter School - Course / Training / Workshop (The Rembrandt Hotel, London) The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. WHAT YOU WILL LEARN FROM THIS COURSE ■ The multiple and complex stages and procedures involved in the development of a new drug ■ How many different skills are used in drug development ■ How to relate your own responsibilities to the professional knowledge and needs of others in the chain ■ The pitfalls that can prevent a new drug coming to the market ■ Why drug development is so expensive, and where the money goes ■ Current trends and future prospects for global drug development
Tue, Feb 9, 2010		THE US DRUG APPROVAL PROCESS - Course / Training / Workshop (The Cavendish Hotel, London) General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process Topics covered at this two day meeting: Structure and functions of the FDA ■ Historical background ■ General regulatory requirement ■ Regulation of preclinical and clinical research ■ New drug application process ■ Biologics ■ Special issues ■ Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics With: Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
Wed, Feb 10, 2010		THE US DRUG APPROVAL PROCESS - Course / Training / Workshop (The Cavendish Hotel, London) General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process Topics covered at this two day meeting: Structure and functions of the FDA ■ Historical background ■ General regulatory requirement ■ Regulation of preclinical and clinical research ■ New drug application process ■ Biologics ■ Special issues ■ Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics With: Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
Fri, Feb 26, 2010		The Bacteriophage in Biology, Biotechnology and Medicine - Conference (The BioPark, Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AX, UK.) After our successful Bacteriophage Applications - current and potential applications in biotechnology, agriculture and medicine event which took place 16th May 2006 and Bacteriophages: Nature and Exploitation event which took place in 22 February 2008 we are delighted to announce our follow up event. "Bacteriophages are the most abundant biological entities on earth and are major drivers of bacterial adaptive evolution. Studies on phage biology underpin our core knowledge of modern molecular biology - and phage research has provided many of the techniques and biochemical reagents used by all molecular biologists. This meeting is the third in a successful biennial series discussing the biological nature of bacteriophages, and their exploitation in basic microbiology (for genetics and functional genomics); diagnostics, ecology and evolution, phage display, vaccines, and in therapeutics in animal and human infections. The general structure of the meeting is to have short, expert presentations on this spectrum of topics, plus short Q&A sessions and offered posters. The meeting will be of interest to anyone who is currently using phages in their research work or who might be interested in the potential application of phages for basic biology, and applied topics such as bacterial diagnostics, vaccine development and phage therapy". Meeting chair - Professor George Salmond, University of Cambridge, UK
Mon, Mar 22, 2010		INJECTABLE DRUG DELIVERY - Devices, Technology & Development - Formerly NEEDLE-FREE, PEN AND AUTO INJECTORS - Conference (Hotel to be advised, London) *Call for Papers* If you would like to give a presentation at this event please contact andrea.james@Management-forum.co.uk, Further information will be available shortly. Please contact andrea.james@management-forum.co.uk in the meantime.
Tue, Mar 23, 2010		INJECTABLE DRUG DELIVERY - Devices, Technology & Development - Formerly NEEDLE-FREE, PEN AND AUTO INJECTORS - Conference (Hotel to be advised, London) *Call for Papers* If you would like to give a presentation at this event please contact andrea.james@Management-forum.co.uk, Further information will be available shortly. Please contact andrea.james@management-forum.co.uk in the meantime.
Thu, Apr 15, 2010		Advances in Cell Culture technology - Conference (The BioPark, Hertfordshire , UK ) After our very successful Developments in cell culture technology to enhance cell growth in vitro meeting that took place May 2008 (the agenda can be viewed at www.euroscicon.com/2ndmay08cellculture.pdf) we are pleased to announce this follow up which will again be chaired by Dr Stefan Przyborski, School of Biological and Biomedical Science, Durham University, UK The agenda for this event is under construction. If you have any queries or are interested in speaking at this event please contact meetingsproducer@euroscicon.com
Mon, Jun 7, 2010		Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic) The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.
Tue, Jun 8, 2010		Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic) The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.

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