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Nov 2009
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Tue, Nov 24, 2009


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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.
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
9:00am		 Small Scale Bio-production: Beyond the Flask. - Conference (BioPark Hertfordshire, Welwyn Garden City)
"Once you can produce it in a flask, what next? The focus of this meeting will be on techniques for the bioproduction of usable quantities of biologic materials, specifically recombinant proteins, monoclonal antibodies, cytokines viruses and other secreted cellular products from eukaryotic cells. Topics covered will include expression systems, mammalian vs. insect vs. other, constituitive vs. transient expression, cell culture medium considerations and culture devices for scale-up that can be used in any laboratory. This meeting should show the fastest pathway from discovery to proof of principle and the production of 100 mgs to several grams of product" Meeting Chair: Dr John J.S. Cadwell, President and CEO, FiberCell Systems Inc, USA
Mon, Nov 30, 2009
 Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
Tue, Dec 1, 2009
 Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
Wed, Dec 2, 2009
 Pharma partnering event PharmaVenue - Conference (AB Skipper Hotel Barcelona (Spain))
PharmaVenue offers an unparalleled opportunity to identify new business opportunities and meet decision makers to forge new partnerships in the field of * Innovations, * Generics and * OTC/Healthcare products PharmaVenue can help your business get to the next level through quality one-to-one meetings with senior level executives. Our state-of-the art interactive partnering software enables you to efficiently select the most attractive license opportunities, pre-arrange and conduct many productive business meetings to unlock future revenue streams. * By having access to detailed information on key license projects of each participating company prior to the event and with help of several new interactive networking tools we facilitate the process of screening potential opportunities and partners. * During six weeks, you may easily submit and review meeting requests through the password protected web-site. You will have access to your individual meeting schedule one week prior to the event and may make your final adjustments to your agenda. Our sophisticated software pre-schedules more than 95%* of all meeting requests. * Experience more productive business meetings in two days than in the entire rest of the year.
Wed, Dec 2, 2009
 Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009
 Pharma partnering event PharmaVenue - Conference (AB Skipper Hotel Barcelona (Spain))
PharmaVenue offers an unparalleled opportunity to identify new business opportunities and meet decision makers to forge new partnerships in the field of * Innovations, * Generics and * OTC/Healthcare products PharmaVenue can help your business get to the next level through quality one-to-one meetings with senior level executives. Our state-of-the art interactive partnering software enables you to efficiently select the most attractive license opportunities, pre-arrange and conduct many productive business meetings to unlock future revenue streams. * By having access to detailed information on key license projects of each participating company prior to the event and with help of several new interactive networking tools we facilitate the process of screening potential opportunities and partners. * During six weeks, you may easily submit and review meeting requests through the password protected web-site. You will have access to your individual meeting schedule one week prior to the event and may make your final adjustments to your agenda. Our sophisticated software pre-schedules more than 95%* of all meeting requests. * Experience more productive business meetings in two days than in the entire rest of the year.
Thu, Dec 3, 2009
 Dermatological Advances 2009 Conference - Conference (BSG House, London, UK)
Dermatology is one of the most promising sectors within the global pharmaceutical market. It has witnessed remarkable sales revenues of over $18bn in 2007, and will expand significantly in the next 10 years. Skin infections and disorders such as acne, psoriasis and dermatitis remain major revenue generators for the pharmaceutical and biotech companies. The dermatology market will regain 3.5% growth by 2010, with the development of anti-psoriasis, acne and dermatitis products and treatments (Source: visiongain). Our conference will focus on the advances and innovations in novel drug delivery, therapeutic skin treatments and anti-ageing products, primarily in the developing countries.
Thu, Dec 3, 2009
 RISK MANAGEMENT - Applying it and meeting the Challenges for Industry - Course / Training / Workshop (Harrington Hall Hotel, London)
INTRODUCTION Risk management is a complex operation involving the identification of risk, the assessment of that risk against a target and subsequent reduction or mitigation of the risk to bring it into the realms of acceptability. Within the Pharmaceutical / Biopharmaceutical industry we work with pharmaceutically active materials which are often potentially hazardous to both the patient and to our production operators. As an industry we need to take a holistic approach to controlling these risks. We manage the risks so that we can in a timely manner bring safe, effective medicines to the patient and at the same time do not expose our operators and support staff to health hazards. We need to take a lifecycle approach to risk management from product development through commercial supply. In doing so it is necessary to recognise that whilst the hazard is fixed, the risk can vary. A number of standard tools are available for risk management. Which ones should you use and when? ICH Q9 has recently been incorporated into the GMP for EU, Japan and USA. It is stated to be non-mandatory, but what does this mean in practice. What changes has ICH Q9 brought about for you / your company / your dealings with the regulators? WHO SHOULD ATTEND This seminar will be of particular interest to all personnel who are or will become involved in any of the following pharmaceutical manufacturing activities: ■ Manufacture or QA of API or drug product ■ Manufacturing rationalisation ■ Site transfer for API and / or drug product ■ GMP compliance ■ Management of regulatory QA / manufacturing QA interfaces ■ Design and construction of manufacturing facilities / processes ■ Validation / Cleaning validation ■ Auditing of own company or supplier Personnel from the following backgrounds: ■ Production ■ Quality Assurance ■ Engineering ■ Regulatory Affairs Compliance ■ Project Planners
Fri, Dec 4, 2009
 Dermatological Advances 2009 Conference - Conference (BSG House, London, UK)
Dermatology is one of the most promising sectors within the global pharmaceutical market. It has witnessed remarkable sales revenues of over $18bn in 2007, and will expand significantly in the next 10 years. Skin infections and disorders such as acne, psoriasis and dermatitis remain major revenue generators for the pharmaceutical and biotech companies. The dermatology market will regain 3.5% growth by 2010, with the development of anti-psoriasis, acne and dermatitis products and treatments (Source: visiongain). Our conference will focus on the advances and innovations in novel drug delivery, therapeutic skin treatments and anti-ageing products, primarily in the developing countries.
Fri, Dec 4, 2009
 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
Mon, Dec 7, 2009
 Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Tue, Dec 8, 2009
 Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
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
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
Tue, Jan 26, 2010
8:55am		 World Drug Delivery and Formulation 2010 - Conference (Radisson BLU Scandinavia Hotel, Dusseldorf, Germany)
26-27th January 2010 Radisson BLU Scandinavia Hotel, Dusseldorf, Germany With increasing generic competition, challenging molecules coming through discovery and continual pressure to produce cost-effective drugs, companies are increasingly turning to formulation and delivery to secure the success of current and new drug products. World Drug Delivery and Formulation 2010 is the event this year for both scientific and business leaders working in formulation and delivery to debate the challenges affecting them. This multi stream delivery and formulation event will focus on both scientific and business issues. This will give everyone the perfect opportunity to attend sessions dedicated to their main area of interest, whilst networking with scientific and business peers from across the entire formulation and delivery spectrum.
Wed, Jan 27, 2010
8:55am		 World Drug Delivery and Formulation 2010 - Conference (Radisson BLU Scandinavia Hotel, Dusseldorf, Germany)
26-27th January 2010 Radisson BLU Scandinavia Hotel, Dusseldorf, Germany With increasing generic competition, challenging molecules coming through discovery and continual pressure to produce cost-effective drugs, companies are increasingly turning to formulation and delivery to secure the success of current and new drug products. World Drug Delivery and Formulation 2010 is the event this year for both scientific and business leaders working in formulation and delivery to debate the challenges affecting them. This multi stream delivery and formulation event will focus on both scientific and business issues. This will give everyone the perfect opportunity to attend sessions dedicated to their main area of interest, whilst networking with scientific and business peers from across the entire formulation and delivery spectrum.
Mon, Feb 8, 2010
 Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products - Course / Training / Workshop (Malvern, PA)
Tue, Feb 9, 2010
 Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products - Course / Training / Workshop (Malvern, PA)
Wed, Feb 10, 2010
 5th Annual Drug Delivery Systems Conference - Conference (BSG House, London, UK)
Drug delivery continues to be increasingly important sector in the pharmaceutical industry and has undergone rapid growth in the last few years. Drug delivery technologies are driving growth of pharmaceutical companies and boosting their revenue by extending the product profitable lifecycle through new formulations, combinations and repositioning. The predominant focus of this conference will be in advancements being made in the drug delivery technologies and understanding the regulatory and legal issues faced by the them.
Thu, Feb 11, 2010
 5th Annual Drug Delivery Systems Conference - Conference (BSG House, London, UK)
Drug delivery continues to be increasingly important sector in the pharmaceutical industry and has undergone rapid growth in the last few years. Drug delivery technologies are driving growth of pharmaceutical companies and boosting their revenue by extending the product profitable lifecycle through new formulations, combinations and repositioning. The predominant focus of this conference will be in advancements being made in the drug delivery technologies and understanding the regulatory and legal issues faced by the them.
Wed, Feb 24, 2010
 Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products - Course / Training / Workshop (Malvern, PA)
Thu, Feb 25, 2010
 Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products - Course / Training / Workshop (Malvern, PA)
Tue, Mar 2, 2010
 Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Wed, Mar 3, 2010
 Stability Programs for Product Shelf Life - From Development to Approval - Course / Training / Workshop (Malvern, PA)
Fri, Mar 12, 2010
 Recombinant vaccines - right molecule, right place, right time? - Conference (The BioPark, Hertfordshire, UK)
"Huge technological advances have been made recently in the genomic and post-genomic analyses of pathogens and disease. To exploit these advances for the production of successful recombinant vaccines we need strategies to select appropriate molecules and to deliver them appropriately to stimulate protective immune responses. This meeting will explore both candidate discovery and the tools for delivering vaccines effectively". Meeting Chair: Dr Alasdair Nisbet, Moredun Research Institute, UK. The meeting has CPD approval.
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)
Mon, Mar 22, 2010
 Pharmaceutical Production Batch Record Review - 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)
Tue, Mar 23, 2010
 Pharmaceutical Production Batch Record Review - Course / Training / Workshop (Costa Mesa, CA)
Mon, Jun 7, 2010
 Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic)
The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.
Tue, Jun 8, 2010
 Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic)
The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.
Thu, Oct 7, 2010
 Induced pluripotent stem cells: production and utility in regenerative medicine - Conference (BioPark Hertfordshire , Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AX ,United Kingdom)
Gene delivery technology and iPS cell characterization and subsequent cell differentiation are critical aspects of iPS cell biology. This meeting will address both issues.



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