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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.
Wed, Nov 11, 2009		PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA - Course / Training / Workshop (The Rembrandt Hotel, London) This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Thu, Nov 12, 2009		INHALED DRUG DELIVERY (IDD) - Course / Training / Workshop (Le Meridien Piccadilly, London)
Thu, Nov 12, 2009		PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA - Course / Training / Workshop (The Rembrandt Hotel, London) This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of a case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Fri, Nov 13, 2009		INHALED DRUG DELIVERY (IDD) - Course / Training / Workshop (Le Meridien Piccadilly, London)
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		GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Lands End, Mumbai, India) The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
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		GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Palace, New Delhi, India) The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
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.
Fri, Nov 20, 2009		GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Krishna, Hyderabad, India) The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Mon, Nov 23, 2009		BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application - Conference (Harrington Hall Hotel, London) The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinate the full set of the existing 20 parts in the series. This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.
Tue, Nov 24, 2009		SUPPLIER QUALITY MANAGEMENT - How well do you know your Suppliers and Supply Chain? - Course / Training / Workshop (The Rembrandt Hotel, London) Topics to be Covered: Cost Effectiveness: The current trend is to source raw materials and APIs from outside Europe and the US, Supplies are more often sourced from India and China. Significant Challenges: Identification, Assessment, Approval, Management of the Supply Chain. The Regulatory Authorities: Close attention to how you manage your Supply Chain. The Impact on your Company: The impact of the increased attention from the Regulatory Authorities is felt both on large Pharma companies and smaller Generic manufacturers where the number of product lines present a daunting task if the supply chain is to be effectively managed
Tue, Nov 24, 2009		BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application - Conference (Harrington Hall Hotel, London) The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinate the full set of the existing 20 parts in the series. This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.
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
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.
Wed, Dec 2, 2009		Cleantech Forum XXV- Beijing - Conference (Grand Hyatt Beijing; Beijing, China) Theme: The largest cleantech market goes from niche to mainstream Connect with clean technology leaders from around the world at the longest-running clean technology event series. Cleantech Forum XXV on December 2-3, 2009 in Beijing is one of five international Cleantech Forums, convening 500 global clean technology leaders representing trillions in capital while providing insight into cleantech trends, and investment opportunities. Meet the power players who are still investing, still creating jobs and wealth, stimulating global economic growth during uncertain economic times, driving clean technology market expansion and developing new relationships with government. Attendees have access to plenary sessions, parallel tracks, expert panels, CEO presentations, side programs and an array of informal networking opportunities. Join them at the must-attend China clean technology event of the year. Receive $100 off registration when using promotion code calenderchn09
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		HOW TO WRITE SOPs - Course / Training / Workshop (The Rembrandt Hotel, London)
Fri, Dec 4, 2009		CORRECTIVE AND PREVENTATIVE ACTION (CAPA) AND PROCESS IMPROVEMENT - Course / Training / Workshop (The Rembrandt Hotel, London)
Fri, Dec 4, 2009		THE EU COSMETICS DIRECTIVE AND THE NEW COSMETICS REGULATIONS - Course / Training / Workshop (The Rembrandt Hotel, London) A quick examination of the cosmetic products sold in many European shops will pick up a significant number of products that do not comply with the EU Cosmetic Regulations. This demonstrates that there are many companies who do not understand the requirements. The EU has recently stated that they wish to enforce labelling requirements more vigorously and there are heavy fines for infringements. It is easy for the authorities to walk round any shop selling cosmetics and look at the labels. Even a minor infringement could lead to a time consuming investigation. Although very complex and lengthy, the regulations are actually quite straightforward if they are summarised, explained properly and put into context. The object of this seminar is to do just this in thorough but simple terms. You will learn what the EU Cosmetics Directive is, how to understand and comply with it.
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
Tue, Dec 8, 2009		ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES - Seminar (The Rembrandt Hotel, London, SW7) BENEFIITS IN ATTENDING: Understand the Significance of the Revision of the MDD In Relation to Adverse Incident Reporting Gain an Overview of the Current System In Europe Keep Abreast with GHTF Progress Know the Role of the Data Safety Monitoring Board Understand the Definitions and Classification of Adverse Events Get an Insight into Competent Authorities Expectations Learn What Happens After CE Marking COURSE OBJECTIVES At the end of the course delegates will be able to:- Explain the regulations governing the monitoring and reporting of adverse events Produce an appropriate adverse event form for use during a study Define and classify adverse events occurring during a study Understand the changes in the regulations and how they impact onadverse event reporting WHO SHOULD ATTEND Those responsible for monitoring medical device clinical studies and those involved in adverse event management and reporting in house and in the field, including; clinical and regulatory staff. Clinical Investigators and clinical site staff who conduct medical device clinical studies and would like to learn more about identifying, interpreting and reportingadverse events during the conduct of a device study. With: Janette Benaddi, Chief Executive Officer, Medvance Ltd.
Tue, Dec 8, 2009		EFFECTIVE FAILURE INVESTIGATION - Course / Training / Workshop (Harrington Hall Hotel, London)
Wed, Dec 9, 2009		EFFECTIVE FAILURE INVESTIGATION - Course / Training / Workshop (Harrington Hall Hotel, London)
Thu, Dec 10, 2009		DOCUMENT MANAGEMENT & ARCHIVING - Seminar (The Rembrandt Hotel, London) Discount Available if booked with HOW TO AUDIT REGULATORY AFFAIRS AND CLINICAL TRIALS - A12-4409 - 11 December 2009 Overview It is essential to document and archive clinical trial documents to ensure compliance with GCP. Clinical Researchers and departments which support clinical trials have to prepare, maintain and archive vast numbers of documents to comply with regulatory requirements for running clinical trials. The audit trail of documents must be transparent and available for regulatory inspection. This compact one day course deals with how to set up, manage and archive clinical trial and regulatory documentation to meet regulatory requirements and prepare for inspection of documentation. An overview of the regulatory background which describes the specific requirements of documentation management and archiving is also covered. This course will be ideal for providing evidence of training in this area to regulatory inspectors
Thu, Dec 10, 2009		US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES - Course / Training / Workshop (Hotel to be Advised, London) FURTHER MEETING DETAILS WILL BE AVAILABLE SHORTLY. Please contact andrea.james@management-forum.co.uk
Fri, Dec 11, 2009		HOW TO AUDIT REGULATORY AFFAIRS & CLINICAL TRIALS - Seminar (The Rembrandt Hotel, London) Discount Available if booked with DOCUMENT MANAGEMENT AND ARCHIVING FOR CLINICAL RESEARCH AND REGULATORY AFFAIRS COMPLIANCE - A12-4309 - 10 December 2009 Overview GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about data quality and integrity. This intensive course provides a comprehensive overview of how to carry out GCP audits for regulatory affairs and clinical research activities. It has been specifically designed to develop audit skills in the EU. It will also help ensure that in your audit role you will understand how the audit programme is essential in achieving regulatory GCP compliance. Participants will review the steps involved in preparing for and carrying out GCP audits for Regulatory Affairs and Clinical Trials, including audit checklists and EMEA inspection guidelines for different type of audits, writing the audit report and developing corrective action plans.
Fri, Dec 11, 2009		US FDA QUALITY REQUIREMENTS & CAPA FOR MEDICAL DEVICES - Course / Training / Workshop (Hotel to be Advised, London) FURTHER MEETING DETAILS WILL BE AVAILABLE SHORTLY. Please contact andrea.james@management-forum.co.uk
Fri, Dec 11, 2009		RECURRING QUESTIONS IN BIOTECHNOLOGY AND CHEMISTRY CASE LAW OF THE EPO BOARDS OF APPEAL - AN OVERVIEW FOCUSED ON SOME RECENT DECISIONS AND CONTROVERSIAL POINTS - Course / Training / Workshop (The Rembrandt Hotel, London, SW7) This seminar will provide useful information on European case law in the fields of chemistry and biochemistry, by means of an up to date analysis of decisions of the European Patent Office Boards of Appeal, considering specifically the current topical issues and controversial points. Interaction between speakers and participants will be encouraged throughout the day.
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		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.
Tue, Jan 12, 2010 9:00pm		Biotech Showcase 2010 - Conference Biotech Showcase is a forum devoted to providing biotechnology companies, investors and pharmaceutical executives with an opportunity to meet in one place during the course of one of the largest annual healthcare investor conference that attracts investors and biopharmaceutical executives from around the world. Now in its second year, the event will expand to a second day and include public biotech companies. The two-day program will feature multiple tracks of presenting companies, plenary sessions, an opportunity to schedule one-to-one partnering meetings and networking. The attendees for the showcase will include private and public equity investors, analysts, bankers, biopharmaceutical industry executives and other industry professionals. The Biotech Showcase is produced by Demy-Colton Life Science Advisors and EBD Group. Both organizations have a long history of providing high quality business support services to the biotechnology industry.
Wed, Jan 13, 2010 9:00pm		Biotech Showcase 2010 - Conference Biotech Showcase is a forum devoted to providing biotechnology companies, investors and pharmaceutical executives with an opportunity to meet in one place during the course of one of the largest annual healthcare investor conference that attracts investors and biopharmaceutical executives from around the world. Now in its second year, the event will expand to a second day and include public biotech companies. The two-day program will feature multiple tracks of presenting companies, plenary sessions, an opportunity to schedule one-to-one partnering meetings and networking. The attendees for the showcase will include private and public equity investors, analysts, bankers, biopharmaceutical industry executives and other industry professionals. The Biotech Showcase is produced by Demy-Colton Life Science Advisors and EBD Group. Both organizations have a long history of providing high quality business support services to the biotechnology industry.
Mon, Jan 18, 2010		FDA APPROVAL PROCESS FOR MEDICAL DEVICES - Course / Training / Workshop (The Rembrandt Hotel, London) 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. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA), Discover what to include in an annual report
Tue, Jan 19, 2010		FDA APPROVAL PROCESS FOR MEDICAL DEVICES - Course / Training / Workshop (The Rembrandt Hotel, London) 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. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA), Discover what to include in an annual report
Tue, Jan 19, 2010		CALIBRATION - The Risk Based Approach to Calibration Management - A Preview of the NEW ISPE Good Practice Guide - out in 2010 - Course / Training / Workshop (The Rembrandt Hotel, London, SW7)
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		CALIBRATION - The Risk Based Approach to Calibration Management - A Preview of the NEW ISPE Good Practice Guide - out in 2010 - Course / Training / Workshop (The Rembrandt Hotel, London, SW7)
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, Jan 25, 2010		DEALING WITH DIFFICULT PEOPLE - A repeat of this successful course - Seminar (Harrington Hall Hotel, London)
Tue, Jan 26, 2010		COPD & ASTHMA - AN INTRODUCTORY COURSE - Course / Training / Workshop (The Rembrandt Hotel, London, UK) TOPICS TO BE COVERED: Aetiology, pathophysiology & current management of COPD & Asthma, New Therapies for Asthma & COPD, Clinical Trials in Asthma & COPD, Regulatory aspects of Asthma & COPD Clinical Trials. This one-day course is intended to provide a sound basic knowledge and understanding of the pathopysiology and management of these key respiratory diseases, together with insight into potential new therapies and clinical trial design. This course will be of benefit to all those requiring a basic knowledge of Asthma and COPD including clinical research and regulatory staff of all levels of seniority who are new to the respiratory field.
Tue, Jan 26, 2010		NEURO LINGUISTIC PROGRAMMING IN THE WORKPLACE - Course / Training / Workshop (Harrington Hall Hotel, London, UK) What Is NLP? NLP (Neuro-Linguistic Programming) is a huge subject. This one day programme aims to look at introducing some of the fundamental pillars of NLP and to provide a basic insight into this powerful set of tools and to explore how they can be used within the world of work. This seminar will cover a brief overview of Neuro-Linguistic Programming and its history. In this session we will also go through the programme and objectives: Enrich your use of language to inspire,motivate and challenge yourself, clients and colleagues, Enhance your ability to build deep levels of rapport, Learn how to develop well-formed outcomes, Increase your influence overyourself and others through a greater understanding ofmeta-programmes and sorting patterns, Use timelines for developing strategies for accelerating change in yourself and others
Wed, Jan 27, 2010		THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role - Conference (The Rembrandt Hotel, London) This interactive course will provide you with the skills and knowledge to be a successful and effective CRA or member of Clinical Trial Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include: Planning and preparation for setting up clinical trials, Understanding the responsibilities at both the study site and the sponsor site, How to carry out the crucial study site visits including, How to prepare for an audit and/or regulatory inspection, Technological advances on collecting data - EDC, On finishing the course you will then be up to date on the latest regulatory GCP requirements including the EU Clinical Trial Directive and Implementation texts, and the GCP Directive.
Thu, Jan 28, 2010		THE EFFECTIVE CRA/CLINICAL TRIAL COORDINATOR - How to be more proactive in your role - Conference (The Rembrandt Hotel, London) This interactive course will provide you with the skills and knowledge to be a successful and effective CRA or member of Clinical Trial Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include: Planning and preparation for setting up clinical trials, Understanding the responsibilities at both the study site and the sponsor site, How to carry out the crucial study site visits including, How to prepare for an audit and/or regulatory inspection, Technological advances on collecting data - EDC, On finishing the course you will then be up to date on the latest regulatory GCP requirements including the EU Clinical Trial Directive and Implementation texts, and the GCP Directive.
Thu, Jan 28, 2010		BASIC PUBLICATIONS PLANNING - Seminar (The Rembrandt Hotel, London) Full information will follow shortly on this new and exciting event. Should you have any questions in the meantime, please contact Sarah Spanswick on sarah@management-forum.co.uk
Thu, Jan 28, 2010		MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London) Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Fri, Jan 29, 2010		ADVANCED PUBLICATIONS PLANNING - Seminar (The Rembrandt Hotel, London) Full information will follow shortly on this new and exciting event. Should you have any questions in the meantime, please contact Sarah Spanswick on sarah@management-forum.co.uk
Fri, Jan 29, 2010		MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London) Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
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
Thu, Feb 4, 2010		PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Saudi Arabia, Syria, UAE and Yemen - Course / Training / Workshop (The Rembrandt Hotel, London) The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in the Middle East, incuding Turkey and Israel, focusing on the practical aspects to assist regulatory activities in the region and will include opportunities for interactive discussions/break-out sessions.
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
Fri, Feb 5, 2010		PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Saudi Arabia, Syria, UAE and Yemen - Course / Training / Workshop (The Rembrandt Hotel, London) The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in the Middle East, incuding Turkey and Israel, focusing on the practical aspects to assist regulatory activities in the region and will include opportunities for interactive discussions/break-out sessions.
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
Wed, Mar 10, 2010		SUCCESSFUL MEDICAL WRITING - Conference (Hotel Majestic Barcelona, Spain) 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 intensive practical medical writing course will benefit participants by enabling them to achieve this standard.
Thu, Mar 11, 2010		SUCCESSFUL MEDICAL WRITING - Conference (Hotel Majestic Barcelona, Spain) 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 intensive practical medical writing course will benefit participants by enabling them to achieve this standard.
Fri, Mar 12, 2010		SUCCESSFUL MEDICAL WRITING - Conference (Hotel Majestic Barcelona, Spain) 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 intensive practical medical writing course will benefit participants by enabling them to achieve this standard.
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.
Wed, Apr 14, 2010		NASAL DRUG DELIVERY - Course / Training / Workshop (Hote to be Advised, London) If you are interested in giving a presentation at this event please contact Andrea James on andrea.james@management-forum.co.uk. Exhibition opportunities are also available. Further information will be available soon. Please contact Andrea James on andrea.james@management-forum.co.uk in the meantime should you wish to know more about this conference.
Thu, Apr 15, 2010		NASAL DRUG DELIVERY - Course / Training / Workshop (Hote to be Advised, London) If you are interested in giving a presentation at this event please contact Andrea James on andrea.james@management-forum.co.uk. Exhibition opportunities are also available. Further information will be available soon. Please contact Andrea James on andrea.james@management-forum.co.uk in the meantime should you wish to know more about this conference.
Tue, May 25, 2010		PRE-FILLED SYRINGES AND ADVANCED INJECTION TECHNOLOGIES - 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.
Wed, May 26, 2010		PRE-FILLED SYRINGES AND ADVANCED INJECTION TECHNOLOGIES - 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.
Sun, May 30, 2010		PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST - To be held in Dubai - Conference (Hotel to be advised, Dubai) The aim of this seminar is to provide you with: An understanding of the key areas of regulatory affairs, A focus on the Middle East including Israel, A focus on the practical aspects to assist with regulatory activities in the region, The opportunity for you to participate in interactive discussions, Break-out sessions, The opportunity to exchange experiences with other delegates
Mon, May 31, 2010		PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST - To be held in Dubai - Conference (Hotel to be advised, Dubai) The aim of this seminar is to provide you with: An understanding of the key areas of regulatory affairs, A focus on the Middle East including Israel, A focus on the practical aspects to assist with regulatory activities in the region, The opportunity for you to participate in interactive discussions, Break-out sessions, The opportunity to exchange experiences with other delegates
Thu, Jul 1, 2010		EU PHARMACEUTICAL REGULATIONS ~ For the Pharmaceutical and Biotechnology Industries - An up-to-date Overview of Current EU Requirements - Course / Training / Workshop (Hotel to be Advised, London, UK) Regulatory Affairs has an acknowledged important role in the pharmaceutical industry, both in obtaining and maintaining marketing authorisations, therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar will: Explain how to obtain and maintain marketing authorisations, Provide an up-to-date overview of current EU regulatory requirements and procedures, Offer interactive presentations, Include two workshops designed to look at the practical implementation, Consolidate the information presented during the two days.
Fri, Jul 2, 2010		EU PHARMACEUTICAL REGULATIONS ~ For the Pharmaceutical and Biotechnology Industries - An up-to-date Overview of Current EU Requirements - Course / Training / Workshop (Hotel to be Advised, London, UK) Regulatory Affairs has an acknowledged important role in the pharmaceutical industry, both in obtaining and maintaining marketing authorisations, therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar will: Explain how to obtain and maintain marketing authorisations, Provide an up-to-date overview of current EU regulatory requirements and procedures, Offer interactive presentations, Include two workshops designed to look at the practical implementation, Consolidate the information presented during the two days.

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