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

Why Should You Attend: Many GCP compliance programs focus too much on and "audit and correct" approach. FDA takes a systems base approach towards compliance and implementation of such an approach by the Sponsor, the CRO, and the Clinical Site increases the likelihood of maintaining an acceptable level of compliance. In this webinar you will learn to see GCP compliance as an interaction of several sub-systems the work together to ensure patient safety and ethical treatment.

Areas Covered in the Seminar:
Background for Clinical Trials and GCP (Good Clinical Practice)
The benefits of a Quality System approach
GCP Quality System
The Importance of the sub-systems: PI Oversight and Record Keeping; IRB Oversight; Monitoring; Clinical Staff and 3rd Party Qualification; IP Handling; Pharmacovigilance/Patient Safety
GCP Compliance Audits
Ranking the Severity of Observations
Resolutions of Deviations
References
Who Will Benefit:
Auditors
Study Coordinators
Managers
Directors
Principle Investigators

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Why Should You Attend:

The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit, either at a clinical site or their headquarters. One of the important aspect of managing a clinical trial is drug accountability.

An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes. When drug accountability records are well designed and error-free, and appropriately reconcile from initial shipment to the site through final disposition, this statement should hold true.

This course will help you to prepare early and help to prevent surprises when being audited. Learn to efficiently manage drug accountability. This program will also share the ”audit experience”, by sharing what auditors look for in term of drug compliance and accountability and how to prepare for the visit. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance..

Areas Covered in the Seminar:

- Investigational Drug Shipment.
- Drug accountability at the investigative site.
- Documentation in Key to accountability.
- Ensuring Compliance and reconciliation.
- Corrections.
- Monitors.
- Drug Return or destruction.
- What auditors observe?
- FDA inspection findings- Warning letters.

Why Should You Attend:

China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.

This 6-hr course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the SFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Why Should You Attend:

Conducting clinical trials and collecting accurate and viable data is an essential and costly component of the drug development paradigm. Sponsors, CROs and 3rd party vendors are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. In the larger research community, clinical trials may have subject matter experts, Although the pharma industry is moving forward with electronic data transfer for many aspects of a trial, how those data are collected, reviewed, archived and retrieved is an arduous task for clinical teams. With collaborative partnerships and data sharing to rapidly address patient needs, data sharing and transport must safeguard the integrity of the data and at the same time ensure patient privacy. Many of the clinical trial team must understand the nature of any legal, regulatory, proprietary or ethical restrictions that may impinge upon a proposed data exchange and complying with HIPAA Privacy Rule (45 CFR Part 160 and Part 164 Subparts A and E).

Areas Covered in the Seminar:

- Documentation requirements for a trial based on the protocol and the geographical location
- Documentation needs in the context of paper, electronic and hybrid document management systems
- Roles and responsibilities of the team members with regards to the trial documentation;
- Roles from the Sponsor, site and CRO perspective
- SOPs required to run the trial and who has responsibility for them
Essential Document List
- Trial Master File and differences from the Essential Document list
- Audits: Site, CRO and in-process trial audits
- Data Sharing with Researchers, Data Safety Monitoring Boards and HIPAA Privacy Rule (45 CFR Part 160)
- Benefits and Requirements of Electronic Data Use Agreements and Organizational Framework (SOPs)

Achieving complete and efficient reporting of adverse drug reactions is a critical goal for all companies involved in developing and delivering medicinal products to the world’s population. These companies include pharmaceutical, biotech, medical device, contract research organisations (CROs), charitable and not-for-profit organisations and academic institutions.

While the challenge of efficient and effective safety reporting to two of the major regulatory agencies – FDA and EMA – is substantial, the additional challenge of reporting to the Japanese regulatory authority, the PMDA, in a way that integrates with an existing safety reporting process and function is significantly greater.

Argus Safety and Argus Safety Japan together help you to meet these challenges by providing a single global database and integrated workflow process for superior safety reporting capabilities.

This webinar will be of interest and relevance to all organisations that need a robust and proven safety system to meet their global regulatory reporting requirements. It will be of particular interest to those companies that have a requirement to report safety events to the PDMA in Japan in a timely and efficient manner that is integrated within their global safety reporting functions.

This webinar will provide you with:

-An overview and the business benefits of Oracle Argus Safety Suite
-The business benefits of Oracle Argus Safety Japan and integrating it with Oracle Argus Safety
-The benefits of a single global safety database and why Oracle Argus Safety Suite is the right solution for it

Tuesday, September 13, 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

This seminar will discuss the new requirements, differences from the older requirements, and tips to not only be compliant but processes to document how you address safety events in your clinical trials. Topics covered include

- What has changed from earlier?
- How do these changes impact ongoing and recently completed clinical trials?
- Best practices to implement new safety reporting processes
- Do's and Don'ts of safety reporting

Areas Covered in the Seminar:

- Current regulatory requirements.
- Rationale for these changes.
- Role of clinical investigators and sponsors.
- Amending existing SOPs and/or creating new ones.
- Training requirements for personnel.
- Good documentation practices for safety monitoring.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

- QA/QC/Compliance/Regulatory affairs professionals
- Clinical trial professionals (e.g., CRAs, coordinators, nurses, pharmacists)
- Investigators participating in clinical trials
- Sponsors and investigator-sponsors of clinical trials
- Pharmacovigilance professionals
- Clinical trial specialists
- Project Managers

This presentation will provide recommendations on various ethical aspects of the performance clinical trials for treating, preventing or diagnosing a disease or condition in paediatrics. This presentation will explain how to ensure paediatric studies must be child and family-focused if they are to run safely, smoothly and to schedule by complying with the he EU Clinical Trial Directive guideline which provides excellent guidance on how to run ethically sound clinical trials in children. A practical, step-by-step guide to running successful clinical trials in paediatrics will be given to help ensure compliance.

Areas Covered in the Seminar:

- Learn how to plan and manage successful clinical trials in paedeiatrics
- Understand the latest regulatory guidelines and how it will impact your clinical trials in practice
- What are the considerations for consent and assent?
- What are the practical requirements for running paediatric clinical trials?
- Appreciate the demands of paediatric populations and how this will impact your trial
- What are the special requirements for ethical review?
- How to reduce fear and distress?
- What are the recommendations for bodyweight and volumes of blood that can be taken?
- How to avoid unnecessary duplication of trials?
- What about the standards for non-EU countries for running clinical trials?

Who Will Benefit:

This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct clinical trials for pharmaceutical, biotechnology, and biologics products in paediatrics.

- Clinical Development managers and personnel
- Clinical research associates
- Clinical Research archiving and document management personnel
- Quality assurance managers and auditors
- Clinical Development managers and personnel
- Consultants

Overview: This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan.

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments and critical facility systems. We will provide templates for risk assessment and validation strategy. A case study will illustrate the time lines, cost savings and benefits of a risk-based validation master plan.

In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the FDA-preferred method for determining what qualification protocols are required. It is based on the intended use of the equipment and the impact it may have on regulated processes, safety and quality. This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. It includes a specific real-life project involving over 100 separate pieces of equipment and utilities, and the regulatory inspector’s subsequent comments.

Areas Covered In the Session:

Risk-Based Equipment Validation
Equipment and Utility Qualification
Risk management Tools
Functional Risk Analysis
Risk Scoring
Risk Mitigation
Score-Based Validation
Project Outcomes

Who will benefit: This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.

End-users responsible for applications and systems
QA Managers and Personnel
Facility Managers and Personnel
Senior Quality, Regulatory and Operations Management
Regulatory Affairs staff
Quality System Auditors

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Oracle’s Life Sciences Data Hub (LSH) is a framework that allows sponsors and clinical research organizations to manage clinical trial research data.

One of the most difficult tasks in clinical research is the ability to rapidly bring together and analyze all the relevant data from multiple clinical trials for specific patient subpopulations. This information can be used for many business objectives including monitoring safety risks, planning future trials, and product defense.

Join BioPharm Systems’ Michael Grossman, vice president of clinical data warehousing and analytics, for a free one-hour session on an application within LSH that allows users to dynamically select patient subpopulations and automatically deliver the longitudinal data for those subpopulations for detailed analysis.

You will learn how LSH can:

>Provide dynamic selection of patient subpopulations and automatically generate a longitudinal data mart of the selected subpopulation

>Save and reuse analysis methods and results for future analysis and exploration

Wednesday, June 22, 2011 @

11:00 a.m. Pacific
12:00 p.m. Mountain
1:00 p.m. Central
2:00 p.m. Eastern
7:00 p.m. GMT