Search Results


Mon, Nov 9, 2009		Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval - Course / Training / Workshop (Malvern, PA)
Tue, Nov 10, 2009		Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval - Course / Training / Workshop (Malvern, PA)
Wed, Nov 11, 2009		Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval - Course / Training / Workshop (Malvern, PA)
Thu, Nov 12, 2009		INHALED DRUG DELIVERY (IDD) - Course / Training / Workshop (Le Meridien Piccadilly, London)
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		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		Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
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.
Wed, Nov 18, 2009 9:00am		REGULATORY BASICS 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 regulatory strategy and operations. It will teach the essentials of regulatory project management, with a focus on how these skills can be applied in the process of creating an initial Investigational New Drug (IND) application. Through the use of lectures, discussions and case studies, participants will learn about the key elements of the regulatory process in the United States, discuss the required elements of an IND, the utility of the Clinical Trials Directive (CTD) for building a foundation for continued development and other key topics. Who will benefit: This course will be beneficial to those new to regulatory affairs as well as those with regulatory experience but limited exposure to the early phases of development stage work in the pharmaceutical and biotech industries. Managers who are not versed in regulatory, but are involved with clinical trial programs will also benefit. Key topics: * What is an IND? * The Pre-IND Meeting - Dos and Don'ts * What is FDA looking for in the initial application * Is the CTD an option? * Timeline management * Submission and post submission success Learning Outcomes: * Understanding of the IND process and key decision points * Understanding of how regulatory strategy drives decisions in the drug development process * Recognition of regulatory hurdles * Knowledge of how to build effective submissions * Recognition of the need to effectively manage expectations and timelines For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Thu, Nov 19, 2009		Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
Thu, Nov 19, 2009		Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Malvern, PA)
Thu, Nov 19, 2009		Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products - Course / Training / Workshop (Malvern, PA)
Fri, Nov 20, 2009		Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
Fri, Nov 20, 2009		Adverse Drug Events - Reporting & Regulatory Requirements - Course / Training / Workshop (Malvern, PA)
Fri, Nov 20, 2009		Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products - Course / Training / Workshop (Malvern, PA)
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		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		Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Course / Training / Workshop (Malvern, PA)
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
Thu, Dec 3, 2009		Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities - Course / Training / Workshop (Malvern, PA)
Thu, Dec 3, 2009		How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices - Course / Training / Workshop (Malvern, PA)
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		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		Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities - Course / Training / Workshop (Malvern, PA)
Fri, Dec 4, 2009		How to Develop an Effective Complaint Handling and Post Market Surveillance Program for Drugs and Devices - Course / Training / Workshop (Malvern, PA)
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.
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.
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.
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.
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.
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 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		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
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
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		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 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
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, 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.
Sun, Apr 11, 2010		SBS 16th Annual Conference & Exhibition - Conference (Phoenix Convention Center, Phoenix, AZ, USA) Advancing the Science of Drug Discovery
Mon, Apr 12, 2010		SBS 16th Annual Conference & Exhibition - Conference (Phoenix Convention Center, Phoenix, AZ, USA) Advancing the Science of Drug Discovery
Tue, Apr 13, 2010		SBS 16th Annual Conference & Exhibition - Conference (Phoenix Convention Center, Phoenix, AZ, USA) Advancing the Science of Drug Discovery
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.
Wed, Apr 14, 2010		SBS 16th Annual Conference & Exhibition - Conference (Phoenix Convention Center, Phoenix, AZ, USA) Advancing the Science of Drug Discovery
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.
Thu, Apr 15, 2010		SBS 16th Annual Conference & Exhibition - Conference (Phoenix Convention Center, Phoenix, AZ, USA) Advancing the Science of Drug Discovery
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, Feb 24, 2011		The Global Public Health implications of Tropical Diseases Research - Conference (The BioPark, Hertfordshire, UK) "Although there is a rush of technological advancement in the tropical countries, by accepting the super technological approach in handling diseases like cardiovascular diseases, kidney diseases, diabetes, rare neurological disease etc, the most commonly encountered diseases in the tropical countries, such as infectious diseases (leprosy, drug resistant tuberculosis, leishmanissis,malaria filariais as well as common cancers like oral cancer and immunodeficiency vs malnutrition) are not getting enough attention. This meeting will explore the new technological advances and research currently being undertaken to irradicate these neglected diseases and discuss the greater implications these will have to global public health". Meeting Chair: Professor P.K. Das, University of Amsterdam, The Netherlands . The meeting has CPD approval.

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