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Fri, Nov 27, 2009

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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		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		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.
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
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		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.
Wed, Jan 13, 2010		PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach - Course / Training / Workshop (Harrington Hall Hotel, London) "Say what you do and do what you say" - and DOCUMENT IT! This seminar will focus on changes to GMP stimulated by the introduction of ICH Q10 on Pharmaceutical Quality Systems (PQS) with main focus on changes to Chapter 4 on Documentation of EU GMP. ■ What is the impact of ICH Q10 and proposed Changes to EU GMP Chapter 4 on Documentation for the GMP Environment? ■ The framework for a Pharmaceutical Quality System ■ Understanding the Difference between Instructions and Records propsed by these Changes to EU GMP ■ How good are your SOPs (Instructions) and the Evidence of Actions (Records)?
Thu, Jan 14, 2010		PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach - Course / Training / Workshop (Harrington Hall Hotel, London) "Say what you do and do what you say" - and DOCUMENT IT! This seminar will focus on changes to GMP stimulated by the introduction of ICH Q10 on Pharmaceutical Quality Systems (PQS) with main focus on changes to Chapter 4 on Documentation of EU GMP. ■ What is the impact of ICH Q10 and proposed Changes to EU GMP Chapter 4 on Documentation for the GMP Environment? ■ The framework for a Pharmaceutical Quality System ■ Understanding the Difference between Instructions and Records propsed by these Changes to EU GMP ■ How good are your SOPs (Instructions) and the Evidence of Actions (Records)?
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		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
Mon, Jan 25, 2010		DEALING WITH DIFFICULT PEOPLE - A repeat of this successful course - Seminar (Harrington Hall Hotel, London)
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
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
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
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.
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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