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Nov 2009
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Tue, Nov 24, 2009


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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
Mon, Nov 30, 2009
 Good Manufacturing Practices - Course / Training / Workshop (Costa Mesa, CA)
Tue, Dec 1, 2009
 Good Manufacturing Practices - Course / Training / Workshop (Costa Mesa, CA)
Wed, Dec 2, 2009
 Good Manufacturing Practices - Course / Training / Workshop (Costa Mesa, CA)
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
 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, 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
Wed, Jan 27, 2010
 Good Manufacturing Practices - Course / Training / Workshop (Malvern, PA)
Thu, Jan 28, 2010
 Good Manufacturing Practices - Course / Training / Workshop (Malvern, PA)
Fri, Jan 29, 2010
 Good Manufacturing Practices - Course / Training / Workshop (Malvern, PA)
Sun, Feb 28, 2010
9:00am		 Pittcon 2010 Conference and Exposition - Conference (Orange County Convention Center)
Pittcon is the world's largest annual conference and exposition for laboratory science. Pittcon 2010 is the premier meeting place for the inventors, users, manufacturers, and vendors of laboratory instruments, equipment and supplies. Pittcon features the world's largest exposition of instrumentation, a diverse Technical Program, unique networking opportunities, and professional-quality Short Courses.
Mon, Mar 1, 2010
9:00am		 Pittcon 2010 Conference and Exposition - Conference (Orange County Convention Center)
Pittcon is the world's largest annual conference and exposition for laboratory science. Pittcon 2010 is the premier meeting place for the inventors, users, manufacturers, and vendors of laboratory instruments, equipment and supplies. Pittcon features the world's largest exposition of instrumentation, a diverse Technical Program, unique networking opportunities, and professional-quality Short Courses.
Tue, Mar 2, 2010
9:00am		 Pittcon 2010 Conference and Exposition - Conference (Orange County Convention Center)
Pittcon is the world's largest annual conference and exposition for laboratory science. Pittcon 2010 is the premier meeting place for the inventors, users, manufacturers, and vendors of laboratory instruments, equipment and supplies. Pittcon features the world's largest exposition of instrumentation, a diverse Technical Program, unique networking opportunities, and professional-quality Short Courses.
Wed, Mar 3, 2010
9:00am		 Pittcon 2010 Conference and Exposition - Conference (Orange County Convention Center)
Pittcon is the world's largest annual conference and exposition for laboratory science. Pittcon 2010 is the premier meeting place for the inventors, users, manufacturers, and vendors of laboratory instruments, equipment and supplies. Pittcon features the world's largest exposition of instrumentation, a diverse Technical Program, unique networking opportunities, and professional-quality Short Courses.
Thu, Mar 4, 2010
9:00am		 Pittcon 2010 Conference and Exposition - Conference (Orange County Convention Center)
Pittcon is the world's largest annual conference and exposition for laboratory science. Pittcon 2010 is the premier meeting place for the inventors, users, manufacturers, and vendors of laboratory instruments, equipment and supplies. Pittcon features the world's largest exposition of instrumentation, a diverse Technical Program, unique networking opportunities, and professional-quality Short Courses.
Fri, Mar 5, 2010
9:00am		 Pittcon 2010 Conference and Exposition - Conference (Orange County Convention Center)
Pittcon is the world's largest annual conference and exposition for laboratory science. Pittcon 2010 is the premier meeting place for the inventors, users, manufacturers, and vendors of laboratory instruments, equipment and supplies. Pittcon features the world's largest exposition of instrumentation, a diverse Technical Program, unique networking opportunities, and professional-quality Short Courses.
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.
Mon, Mar 22, 2010
 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products - Course / Training / Workshop (Costa Mesa, CA)
Tue, Mar 23, 2010
 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products - Course / Training / Workshop (Costa Mesa, CA)
Fri, Jun 11, 2010
 Recombinant pharmaceutical manufacturing from plants - the future of molecular farming - Conference (The BioPark, Hertfordshire, UK )
After our very successful 'Molecular Farming - plant biologicals' event in 2008 we are pleased to announce this follow up event which will be chaired again by Professor Julian K-C. Ma, Hotung Chair of Molecular Immunology, St. George's, University of London, 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



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