Who: Param Singh, vice president of clinical trial management solutions, BioPharm Systems

Adrian Hampshire, managing director, EMEA, BioPharm Systems

Paul Dobrowolskyj, senior consultant, Oracle Health Sciences

What: Webinar: "Business and Operational Risks in Clinical and Safety: Applying Appropriate Technology and Approaches to Mitigate Risk"

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company's business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

When: Thursday, November 17, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

Webinar Information: To register for this complimentary webinar, go to: https://cc.readytalk.com/r/bf2hph6dutcu

NelsonHall and buyingTeam recently ran a study involving 120 CPOs and CFOs from FTSE 100 organisations across Europe and the US to better understand procurement’s changing role within business today and tomorrow.

Focusing on indirect (or non-core / GNFR) procurement, the in-depth study identified a number of challenges and opportunities for global businesses in realising maximum benefits from indirect expenditure.

Nearly 60% of Board level executives, perceived indirect procurement's importance as moderate to low (or putting it another way, place little importance on the value that indirect procurement can deliver back to the business).

However, experience has shown that better managed indirect expenditure can deliver significant profit improvements, reduce the levels of risk to which organisations are exposed, and positively influence buying behaviours across the organisation.

So why isn’t indirect procurement higher up senior executives agenda and how can organisations overcome these perceptual challenges?

During the 60 minute discussion you will hear:
- Current perceptions of the indirect procurement function and its desired future role within the organization
- The challenges currently faced by the indirect procurement function
- The business value that can be derived through indirect procurement
- The role of procurement outsourcing in enabling the indirect procurement function to take on a business partner role within the organisation.

Why Should You Attend:

The SEC is currently committed to US adoption of IFRS including a published implementation timeline. Therefore it is necessary for all organizations to understand IFRS requirements as well as the short and long term effect that implementation will have on the financial reporting and disclosure process.

The discussion will include the current status of convergence and adoption. The course explores the major differences, both cosmetic and substantive, between U.S. GAAP and IFRS. You will learn the Standards requirements associated with financial statement preparation and presentation as well as assets, liabilities, equity and revenue. A sample financial statement will be presented. In addition, private entity options will be discussed.

IFRS adoption presents numerous potential challenges. The aforementioned will be offered for deliberation. Transition considerations and implementation risks will be presented which will allow participants to consider the implications for their organization.

Duration:

6 hours of instruction, one hour lunch, 15 min breaks as appropriate.

Who Will Benefit:

- CEO's, CFO's, Controllers
- Accounting, Finance and/or Financial Reporting
- Business managers and Unit/Department Heads

Why Should You Attend:

The SEC is currently committed to US adoption of IFRS including a published implementation timeline. Therefore it is necessary for all organizations to understand IFRS requirements as well as the short and long term effect that implementation will have on the financial reporting and disclosure process.

The discussion will include the current status of convergence and adoption. The course explores the major differences, both cosmetic and substantive, between U.S. GAAP and IFRS. You will learn the Standards requirements associated with financial statement preparation and presentation as well as assets, liabilities, equity and revenue. A sample financial statement will be presented. In addition, private entity options will be discussed.

IFRS adoption presents numerous potential challenges. The aforementioned will be offered for deliberation. Transition considerations and implementation risks will be presented which will allow participants to consider the implications for their organization.

Duration:

6 hours of instruction, one hour lunch, 15 min breaks as appropriate.

Who Will Benefit:

- CEO's, CFO's, Controllers
- Accounting, Finance and/or Financial Reporting
- Business managers and Unit/Department Heads

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Date: 4/27/2011 Time: 11:00 AM

Why Should You Attend:

As a result of the FDA and EU Clinical Trials Directive 200/20/EC and subsequent promulgation of laws, EMA inspection and reflection paper in clinical laboratories in the EU covering the conduct of clinical trials in accordance with Good Clinical Practice (GCP), there is the need for laboratories undertaking analysis of samples from clinical trials to comply with GCP regulations and guidance. The standard to be followed by such laboratories is not well defined in FDA and ICH GCP and hence the development of new EMA standards which provides guidance on the standards anticipated which will set the gold standard in the EU and US.

In particular Article 15 of EU Clinical Trials Directive 2001/20/EC provides provision for the inspection of laboratories that perform the analysis or evaluation of samples collected as part of a clinical trial and so companies must ensure the laboratories they use are in compliance with good clinical practice.

The presentation will review the key requirement for compliance for the analysis of samples collected from subjects participating in clinical trials and forms a key part of the clinical trials process. Sample analysis or evaluation provides important data on a range of endpoints which is used, for example, to assess the pharmacokinetic profile of investigational medicinal products and to monitor their safety and efficacy. Consequently, it is essential that sample analysis and evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported.

This presentation will explain the new standards which will be required by laboratories analyzing clinical trial samples. The session is aimed at sponsors using clinical laboratories and those at laboratories who wish to demonstrate to sponsors of clinical trials and government agencies worldwide that the clinical laboratory operates to a standard that assures the reliability, quality and integrity of the work and results generated.

Areas Covered in the Seminar:

What does GCP and the new guidance require of clinical laboratories?
What parts of GCP apply to clinical laboratories?
What standards should the laboratory be working to?
How to assess a clinical laboratory? Sponsor companies should assess the laboratory before placement to ensure that all aspects of GCP are satisfactorily addressed and that the laboratory standards and methods meet GCP requirements.
Facilities, to assess the orderliness, cleanliness and environmental suitability of premises where study specific activities are to be carried out and the arrangements for storage of materials and samples.
Procedures for sample collection, receipt and application of acceptance/rejection criteria and for the preparation of reagents.
What documentation should be available – including SOPs, validation, technical agreements?
What is required to ensure quality and appropriateness of methodology in use in any laboratory?
What should be included in the contract between the laboratory and the sponsor?
What is the role of the sponsor company during the study?
What should be included in the final reports of the analysis?

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.

Why Should You Attend:
This 4 hours webinar explores the unique challenges associated with smaller entities when designing, building and/or assessing a system of internal control. Practical implementation solutions that will effectively strengthen the internal control environment while requiring minimal cost, resources and time will be outlined.

Learn why it is most important to focus on Entity Level controls, the Control Environment as well as Risk Assessment & Fraud for an efficient cost-effective solution. Suggestions for assessment of the current system of internal control will be presented. Implementation options and considerations will be offered which will allow participants to consider appropriate solutions for their organization.

Duration:
4 hours of instruction, 15 min break

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Date: 3/23/2011 Time: 11:00 AM

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Learn how Clearview Premium Edition Documents, the leading ECM software solution leveraging the power of Microsoft Office SharePoint can help you organize your content. Clearview extends and completes the core capabilities of SharePoint with enterprise-class document imaging and high-value content services to deliver an unprecedented ECM solution built exclusively for the Microsoft technology environment.

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Date: 3/23/2011 Time: 11:00 AM

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