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| Highlights of the current calendar include: |
| Forthcoming Masterclasses & Workshops include the following: |
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Masterclass: Preparing for MHRA Pharmacovigilance Inspections
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8th September 2010,
London
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Overview
MHRA pharmacovigilance inspections exist in order to ensure legislation and guidelines relating to drug safety monitoring are adhered to. It is vital for any company that a good result is achieved in inspections and the penalties for failing to comply with GCP legislation can be harsh. Recently, risk based inspections have been introduced which provide a new set of challenges. This |
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Executive Briefing: Biosimilars: Understanding the Regulatory Processes and the Commercial Realities
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21st September 2010,
London
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In association with Interpharm Consultancy
Overview of workshop
The aim of this workshop is to give participants a good overview of the whole topic of biosimilars while investigating in more depth those topics that merit it. Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier, since it is widely thought that lower levels |
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Executive Briefing: Commercialisation of Biomarkers for Personalised Medicine
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22nd September 2010,
London
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Overview
The commercialisation of biomarkers is the final and often most daunting part of the biomarker process. It is crucial that the correct path is taken to ensure your biomarker has the greatest chance of commercial success. In this half-day workshop, various approaches, examples and case studies will be presented and participants will also have the opportunity to raise specific issues and problems that they face or expect to face..... |
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Executive Briefing: Mistakes in CRO selection: What goes wrong & how to solve these problems
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6th October 2010,
London
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In association with
Overview of workshop
Designing for co-operation plays a significant part in outsourcing. If you get it right, then most of the problems, for instance sponsor's satisfaction, take care of themselves. Planning the co-operation starts early in the CRO selection phase, hence it is good to know the most common pitfalls that may later cause problems and even risks t |
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Executive Briefing: Economic Evaluations in Clinical Trials
Strategy, Design, Opportunities and Pitfalls
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26th October 2010,
Munich
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This interactive will explore strategies on how to optimally use randomised clinical trials for economic data collection and economic evaluation.
The need of economic analyses to support pricing, reimbursement and funding of drugs is constantly increasing and several factors, from demography to the aftermaths of the financial crisis, are likely to aggravate this situation. Phase II and III clinical trials are key as potentia |
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Executive Briefing: Improving Target Selection in Drug Discovery for Metabolic Syndrome Therapies
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9th November 2010,
London
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Overview
This workshop will assess the impact of the early project/target selection process on successful market introduction of novel therapies. Pharmaceutical companies may have to change from providers of therapeutics and diagnostics to providers of integrated health care. There is pressure on the industry to come up with new and better rational concepts for drug development. The project/target selection will therefore re |
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Executive Briefing: Overcoming the Low Success Rate of New CNS Drugs
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17th November 2010,
London
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Overview
The discovery and development of drugs to treat conditions affecting the central nervous system continues to be fraught with challenges and difficulties. A major contributor is our incomplete knowledge of the aetiology and pathophysiology of most CNS disorders, including the dementias, neuropathic pain, mood disorders and the psychoses. Other contributing factors are:
Poor predictive validity of animal models..... |
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Executive Briefing: Cold Chain Challenges, Risk Management and Lessons Learned: Case Studies
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30th November 2010,
London
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Overview
This highly interactive workshop will consist of a series of case studies on failed cold chain clinical supplies shipments, and aims to cover risk management, risk mitigation strategies, and a “Lessons Learned” presentation on the workshop outcomes.
The objective of the workshop will be to give attendees the ability to apply lessons learned to their own temperature controlled processes and procedures to improve..... |
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Masterclass: Epigenetic Profiling
Biomarker Discovery to Therapeutic Development
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7th December 2010,
London
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Overview
This masterclass will explore potential applications for epigenetic profiling techonology in drug development. Epigenetics is the study of the regulation of gene expression through non-sequence based factors. It is what links our primary gene sequencing to our environment allowing for differential gene expression, environmental gene modulatio |
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Masterclass: Exploring Lyophilisation
An indepth insight into the Freeze-Drying process design and optimisation
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8th December 2010,
London
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About the Masterclass
Lyophilisation , or freeze-drying is a key practice within the Pharmaceutical industry, as it is necessary for the effective long term storage and transport of biologics and other sensitive materials. However, though the theory is simple the practice is often fraught with challenges and difficulties, as problems such as; optimisation of freezing and drying times; ideal buffer selection; pH fluctuations, and excipient..... |
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Masterclass: Preparing for MHRA Pharmacovigilance Inspections
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7th July 2010,
London
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Overview
MHRA Inspections are an integral and expensive part of modern Pharmacovigilance. It is vital for any company that a good result is achieved as the penalties for non-compliance can be harsh. Recently, risk based inspections have been introduced which provide a new set of challenges. This masterclass will provide you with the tools necessary to prepare for a successful MHRA Inspection.
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Masterclass: Biosimilars MasterClass
Understanding the Regulatory Processes and the Commercial Realities
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6th July 2010,
London
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In association with Interpharm Consultancy
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Masterclass: Social Media Marketing in the Pharma Industry
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5th July 2010,
London
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Overview:
This Masterclass will teach you how to use social media to achieve your key business objectives. The interactive session will take a case-study led approach, looking at examples from both pharmaceutical and other industries. You will learn about the different social media tools and how they can be used to engage with clients, stakeholders and patients. You will also find out how to use social media to grow your business and achiev |
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Masterclass: Social Media in Pharmaceuticals
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14th April 2010,
London
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Overview
The use of social media as a tool for marketing pharmaceutical products has vast potential, but only if used correctly. This SMi masterclass is designed for people in pharmaceutical companies with responsibility for engaging customers and stakeholders, including consumers, patients, healthcare professionals, and patient organisations. The event will benefit both those with no existing |
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Masterclass: Developing Personalized Cancer Therapies
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11th December 2009,
London
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The promise that personalized cancer treatment holds is that patients can be treated as individuals, not merely as members of a “population.” Future cancer treatments will be truly based on the actual biology of the disease.
Key objectives:
UNDERSTAND the concepts of personalized cancer treatment
LEARN |
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Masterclass: Optimising Physical Properties of APIs in Preclinical Development
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9th December 2009,
London
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Overview
Optimising the physical properties of an active pharmaceutical ingredient is a critical phase in the development of a drug candidate. Before the development of the final product, the physical and chemical properties of the API must be investigated. This workshop will look at the properties affecting a compound's synthesis, handling, stability, formulation and most critically its behaviour as a medicine. In addition, proven |
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Masterclass: Accelerating Preclinical CMC Activities
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8th December 2009,
London
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Attrition rates and clinical failures continue to thwart attempts to accelerate new drug development and Chemistry, Manufacturing and Control activities play an important role. Large pharmaceutical companies are rethinking traditional approaches and adopting a flexible strategy to early development. This Masterclass aims to help those working in early drug development to understand the various options open to them and the consequences of..... |
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Masterclass: Intellectual Property and Generics
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8th December 2009,
London
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Intellectual Property, often abbreviated to IP, plays an extremely significant role in the generic world, but not everybody who ought to know about it really understands it. Important matters such as patent issues and data exclusivity are often confused, even though there are significant differences between them.
Benefits of attending:
GAIN an understanding of how IP affects commercial aspects of the generics business
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Masterclass: Data Management in Medical Imaging
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16th July 2009,
London
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The volume of data produced when implementing medical imaging in the Pharmaceutical industry is huge. With applications in drug discovery & development along with clinical trials, data retention policies also mean this data can need to be stored for many years, in accordance with regulatory guidelines. This can present a huge problem to those generating and storing the data. Settling on an efficient data management system can be the key..... |
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Masterclass: Therapeutic vaccines against IgE mediated allergies
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10th December 2008,
London
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Therapeutic vaccines targeting various self molecules is an emerging field of vaccine development that is studied extensively in areas such as birth control, cancer, allergy and autoimmunity. Promising results have come from a number of animal studies and several vaccines are in advanced clinical trials. However, no vaccine is yet on the market. In this workshop we will focus on the progress in the development of vaccines against IgE mediated..... |
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Masterclass: Intellectual Property and Generics Masterclass
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3rd December 2008,
London
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Intellectual Property, often abbreviated to IP, plays an extremely significant role in the generic world, but not everybody who ought to know about it really understands it. The topic includes important matters such as patent issues and data exclusivity and these two are often confused, even though there are significant differences between them. IP issues can affect generic development, registration and launch and making mistakes due to a lack..... |
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Masterclass: Implementing Adaptive Phase II Dose Ranging Studies
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2nd July 2008,
London
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The time and cost pressure on drug development programs, and the current poor rate of success, means there is an increasing need to innovate in drug development. One of the key innovations being looked at are adaptive clinical trials. This masterclass will look at the opportunities, costs, and benefits of using adaptive trial designs in the early phases of drug development. It will also look at the logistical challenges of running adaptive..... |
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Masterclass: Developing and Implementing Pricing and Reimbursement (P&R) Strategies
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1st July 2008,
London
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Because no single factor influences profits more than price, it is imperative to develop an effective pricing strategy. The best price in one market may not be the optimal price in another market yet these price references are a standard for price regulation. Additionally, parallel (cross-border) trade issues are significant problems to consider and can greatly influence pricing. By starting early (i.e. well before approval) it is possible to..... |
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Masterclass: Supply Chain Security
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1st July 2008,
London
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Pharmaceutical products are critical to the social, economic and political stability of societies around the world. No other economic sector is more dependent on consumer confidence and, like food products, they are highly vulnerable to deliberate and/or accidental disruption. The threats industry faces today are categorically different from those of a decade ago and there is a compelling need for industry to secure the entire supply chain...... |
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Masterclass: Pharmaceutical Pricing Megatrends
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5th July 2007,
London
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It’s easy to get lost in the constantly changing detail of pricing regulations. But many of the changes are part of long term trends. What are the big picture trends that give meaning to the myriad of detailed changes? What do they tell us about the future of Pharma pricing? An essential Masterclass for all pricing strategists to find out how you can navigate regulations from regional pricing agencies whilst maintaining a global strategy. ..... |
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Masterclass: RFID - The Magic Pill for Healthcare?
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5th July 2007,
London
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Radio Frequency Identification (RFID) and (bio)Sensors, provide new possibilities for the Life Sciences and Healthcare companies to increase Patient Safety and lower Costs. In this interactive workshop, where participants will apply the material to their own business, Oracle would like to share the latest developments in e-Pedigree, Drug-Counterfeiting, Smart Packaging, Asset & Personnel Tracking and Tele-Medicine with Health-Science..... |
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Masterclass: How to React to Parallel Trade
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4th July 2007,
London
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Few issues have provoked such consistent hostility from pharmaceutical companies in Europe as parallel trade. Yet, despite their efforts, the trade continues to flourish 40 years on, eroding profits in the freer-priced markets. Some might argue that it is precisely because of failed efforts to stamp it out that parallel trade has grown to affect more markets and more products than ever before. It is vital to coolly reassess strategy and focus..... |
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