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Nov 2009
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Tue, Nov 24, 2009


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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
 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 14, 2009
 2nd Annual Oncology Market & Patient Access - Conference (Prague, Czech Republic)
This conference and networking event will present a fresh and original perspective on communicating the value and cost-effectiveness of high-value oncology drugs with payers, HTA assessors and other key stakeholders.
Tue, Dec 15, 2009
 2nd Annual Oncology Market & Patient Access - Conference (Prague, Czech Republic)
This conference and networking event will present a fresh and original perspective on communicating the value and cost-effectiveness of high-value oncology drugs with payers, HTA assessors and other key stakeholders.
Tue, Mar 16, 2010
 Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore)
Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Wed, Mar 17, 2010
 Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore)
Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Thu, Mar 18, 2010
 Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore)
Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Fri, Mar 19, 2010
 Pharma & Biotech Supply Chain Asia 2010 - Conference (Raffles City Convention Centre, Singapore)
Pharma & Biotech Supply Chain Asia 2010 brings together pharmaceutical and biotech manufacturers, clinical researchers, distributors and solution providers to address how the industry can collaborate to further strengthen their supply chain in challenging economic conditions to achieve cost optimization, patient safety, product integrity and security in Asia.
Tue, Mar 30, 2010
 Translational Regenerative Medicine Conference - Conference (BSG House, London, UK)
Regenerative medicine is set to revolutionise healthcare as stem cell, tissue engineering, gene therapy and materials science come together to transform patient treatment. Bringing you the latest in translational applications from leading experts, dont miss this exceptional showcase of medical innovations in this fast-moving field.
Wed, Mar 31, 2010
 Translational Regenerative Medicine Conference - Conference (BSG House, London, UK)
Regenerative medicine is set to revolutionise healthcare as stem cell, tissue engineering, gene therapy and materials science come together to transform patient treatment. Bringing you the latest in translational applications from leading experts, dont miss this exceptional showcase of medical innovations in this fast-moving field.



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