Overview: This interactive webinar provides an overview of techniques used for buying, deploying, validating, and maintaining computer systems used for clinical trials.

Computer systems used in clinical trials manage enrollment, payments, and collection of subject data. These systems must be secure and highly reliable. Often IT, QA, and the users are too busy and inexperienced to implement and maintain a system on an ongoing basis. If you have a new system or an upgrade to install, this course will teach you how to reduce costs and implementation time; typically to one third. Use fill-in-the-blank templates for validation documentation. Learn how to identify risk and mitigate it thereby reducing testing time and resources. Avoid errors that results in 483s and warning letters. Understand the industry standards for required features related to security, data transfer, audit trails, and electronic signatures.

Areas Covered in the Session:
How to significantly lower costs and reduce software implementation time
How to avoid 483s and warning letters
Security and software requirements for electronic records and signatures
Required features

Who Will Benefit:
All system users
IT
QA
Managers
Executives
Software vendors

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

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

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

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

This webinar will review the dynamic changes in the conduct of clinical trials that extend beyond the GxP area with the use of lab information systems requiring computer validation, Software Development Life Cycle (SDLC) considerations with an emphasis on Medical Device trials.

Why Should You Attend:

Conducting clinical trials in a rapidly evolving electronic environment presents a unique challenge to the medical device industry where not only quality (GLP/GMP) plays an essential role – but collecting accurate, maintaining viable data (GCP) as part of continuous process improvement (while mitigating risk) is an essential and critical component of the development paradigm.

The complexity of medical device trials require adherence to 21 CFR Part 11 and Predicate Rules and must work in concert with 21 CFR 832.40. Additionally, many hybridized trials cross into the arena of Proof of Concept to allocate resources to devices and as well as biosimilars as part of the new of investigational products.

This session will review the dynamic changes in the conduct of clinical trials that extend beyond the GxP area with the use of lab information systems requiring computer validation and Software Development Life Cycle (SDLC) considerations. Participants will gain valuable insight into the regulatory requirements and how device trials have traditionally differed from pharmaceutical clinical trials.

Areas Covered in the Seminar:

This webinar will provide a firm foundation into what type of Medical Device trials trail-blaze across the traditional clinical activities which require additional compliance for Electronic Records:

• Review 21 CFR Part 11 and the Predicate Rule;
• Review 21 CFR 832.40;
• Briefly overview actual case studies of what went wrong, how the risk of both financial and criminal liability could have been avoided through proper response to Warning Letters;
• Brief history on the Medical Device Safety Act, Social Media / Patient Reported Outcomes and pending legislation that will impact the medical device, generics as well as biosimilar trials.

Event Details:

Date: August 23, 2012
Time: 10:00 AM-11:00 AM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.

Overview: Many anticancer drugs are not tumor selective. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Preventing a therapeutic level to be achieved in a patient.

An extensive list of unwanted toxicities, some of which may be permanent and serious adverse events that may be fatal are well known. We have been developing a platform of first in class first in man compounds that demonstrate selective uptake into tumor cells. Safer more effective treatment has been demonstrated in xenograft models. This Webinar will discuss the present and future development challenges and strategies in the context of novel drugs with selective delivery properties entering the FDA process for consideration and evolution from clinical research to drug product development.

Why should you attend: To establish and contribute to an enhanced understanding of novel drugs targeting tumor metabolism, more specifically bioenergetics and FDA guidelines for new chemical entities. Unlike many cancer chemotherapeutics these new drugs are selectively taken up into cancer cells. This being of critical importance as the pharmaceutical being delivered, targets the intracellular organelle mitochondria. Such novel “smart drug” delivery features also requiring discussion and consideration of preclinical approaches that would support clinical development in man with the potential need for a clinical research period wherein during clinical studies, how current disease progression measurement methods (CT/PET and RECIST) might be used along with the potential identification of biomarkers and companion diagnostics that could be validated in retrospective studies. The latter possibly being linked to delivery technology or active pharmaceutical mechanism of action or to disease progression markers.

Areas Covered in the Session:
Introduction into nanotechnology drug delivery and needs for improvement
Review of relevant FDA regulation, guidelines and points to consider for manufacturing and drug product composition
Clinical research to support clinical development and protocol preparation for human study working with the FDA
Clinical development planning and path to approvals

Who Will Benefit:
Formulation Scientists and Researchers
Regulatory Affairs Managers, Directors and VPs
Quality Managers, Directors and VPs
Manufacturing Managers, Directors and VPs
Strategic Planning Managers, Directors and VPs

Dr. Shorr obtained his PhD and DIC from the University of London Imperial college Department of Biochemistry, London England where he worked with Prof. Eric Barnard and Oliver Dolly. His thesis described the isolation and characterization of the acetylcholine receptor in mammalian skeletal muscle. His postdoctoral work was with Prof. Robert Lefkowitz and Marc Caron at the Howard Hughes Research Institute Duke University Medical Center, Durham North Carolina where he focused on the isolation and characterization of different beta adrenergic receptors. In addition, while at Duke Dr. Shorr worked with Dr. Jeffrey Stadel to develop an understanding of the interaction of beta adrenergic receptors with G protein subunits and the activation of adenylate cyclase. At SmithKline and French Dr. Shorr was the associate Dir. for the Department of molecular pharmacology reporting to the president of worldwide R&D Dr. Stanley Crook. A focus on receptors and disease pathology continued. Dr. Shorr and his colleagues invented several new materials for electrophoretic separations of proteins and nucleic acids introducing the products to the market place through a newly formed company, AT biochem with the assistance of SmithKline and French and Beckman instruments. The company was later sold to Centocor and FMC. Dr. Shorr also became vice president for research and development at Enzon, Piscataway New Jersey. A drug delivery company focused on the attachment of polyethylene glycol strands to proteins, peptides and small molecule drugs for the treatment of human disease wherein the polyethylene glycol attachment would enhance circulating life time and often improve safety and efficacy. Polyethylene glycol conjugated hemoglobin, polyethylene glycol conjugated glucocerebrosidase, polyethylene glycol conjugated camptothecin, polyethylene glycol conjugated adenosine deaminase, polyethylene glycol conjugated arginine deiminase and polyethylene glycol conjugated alpha interferon were studied in human clinical trials. The approval of polyethylene glycol conjugated alpha interferon in partnership with Schering Plough, NJ, establishing the technology and company as a leader in drug delivery. Dr. Shorr served as vice president for technology and chief scientist for United Therapeutics where he was responsible with others for the invention of longer acting prostacyclin analogs for the treatment of pulmonary hypertension. In addition Dr. Shorr served as Dir. for business development for the State University of New York at Stony Brook biotechnology center and as associate professor in the department of biomolecular engineering. Dr. Shorr and his partner Robert Rodriguez established Altira capital and consulting and worked with Chris Prior PhD to establish Principia a company using human serum albumin conjugates for drug delivery and which was later sold to Human Genome Sciences. Altira capital worked with other groups to establish Cornerstone Pharmaceuticals a company focused on developing cancer metabolism-based drugs and drug delivery systems. The proprietary work described here emerges from Cornerstone Pharmaceuticals where Dr. Shorr is currently CEO and chief scientist. The company's bioenergetics metabolism targeting drugs are in clinical trials. The drug delivery technology described herein is in preparation for clinical study.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

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

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

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

Why Should You Attend:
In recent years the FDA has increased the number of clinical sites and trials that have been inspected and audited. The number of investigators under investigation or disqualified has increased. IRBs have been inspected and issued with 483 letters.

What would happen: If the site enrolls some subjects that don't meet all the entry criteria? Have unreported safety issues? Don't sign the CRF? Are not accurate in reporting the data? Don't follow their own SOP? Are these issues hidden in your monitoring reports or not there at all? The FDA does conduct audits of the sites and will issue 483 letters to either the sites or to sponsors. During a market review of data submitted for example an NDA they can disqualify the data if not consistent, they can disqualify a site if they have had protocol, GCP or SOP deviations. They can disqualify a whole study or application if the issues are systemic. Do you have the processes to assure compliance?

Areas Covered in the Seminar:

• Checking the investigators and IRB qualifications and training.
• Preventive risk mitigation methods including training and monitoring sites.
• Issuing protocol deviations.
• Communication plans with issue escalations and contingency planning.

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing.

Why Should You Attend:

To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline regulatory compliance processes, in particular, the Adverse Event (AE) Reporting during clinical studies and post-marketing. Thus, to establish and maintain a medical device AE reporting and surveillance/vigilance system, it is critical to have a “current, accurate, and complete” (CAC) information and knowledge of compliance requirements in a systematic, integrative (SI) manner on a global basis.

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing. This seminar is a “How To Guide” for empowering those involved and is intended to streamline the processes of adverse event reporting and surveillance/vigilance system in a systematic, integrative
(SI) manner.

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

Why Should You Attend:

In recent years the FDA has increased the number of clinical sites and trials that have been inspected and audited. The number of investigators under investigation or disqualified has increased. IRBs have been inspected and issued with 483 letters.

What would happen: If the site enrolls some subjects that don't meet all the entry criteria? Have unreported safety issues? Don't sign the CRF? Are not accurate in reporting the data? Don't follow their own SOP? Are these issues hidden in your monitoring reports or not there at all? The FDA does conduct audits of the sites and will issue 483 letters to either the sites or to sponsors. During a market review of data submitted for example an NDA they can disqualify the data if not consistent, they can disqualify a site if they have had protocol, GCP or SOP deviations. They can disqualify a whole study or application if the issues are systemic. Do you have the processes to assure compliance?

This webinar will help you understand the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

Areas Covered in the Seminar:

- Checking the investigators and IRB qualifications and training.
- Preventive risk mitigation methods including training and monitoring sites.
- Considerations for protocol violations.
- Issuing protocol deviations.
- Communication plans with issue escalations and contingency planning.
- Monitor report templates.

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.

Why Should You Attend:

To be able to achieve sustainability and to remain sustainable and competitive in global medical product markets, it is necessary to streamline regulatory compliance processes, in particular, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP, it is critical to accurately define, document and implement “current, accurate, and complete” (CAC) requirements pursuant to the relevant and applicable laws and regulations, GCP requirements, and compliance in a systematic, integrative (SI) manner.

This webinar is intended to help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner, all of which are regulated by the United States Food and Drug Administration (FDA). At the end of this webinar, you will leave empowered with the knowledge of applicable FDA regulations and requirements.

This Webinar will help you understand the current FDA requirements regarding financial disclosure in clinical trials. It will discuss differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.

Why Should You Attend:

If your company or organization is sponsoring clinical trials for a drug, biologic medical device or a diagnostic kit; if you are a clinical investigator, co-investigator or sub-investigator participating in a clinical trial; if you are with an IRB overseeing clinical trials, or if you are senior management in a company sponsoring clinical trials, this webinar will help you understand the current FDA requirements regarding financial disclosure.

You can get valuable tips and training in less than an hour on practical methods for collecting financial disclosure information from all clinical investigators in your clinical trial. This webinar will also discuss acceptable methods to collect financial disclosure information from international investigators. This seminar will discuss the new requirements, differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.

Areas Covered in the Seminar:

- Clarification of the definition of financial interest.
- Types of clinical investigator financial interests that you must report..
- How and when to collect and report the financial disclosure information.
- Specific concerns for different kind of products: drug, biologic and medical device.
- Forms to be used for collecting this information.
- What needs to be disclosed?
- Changes in financial disclosure information during a trial.

This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements.

Why Should You Attend:

Clinical Project Managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data, and even other more severe penalties.

This course will provide an overview of regulatory management for clinical trials. We would discuss the key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. Practical tips for regulatory management of a clinical trial project will be provided using case studies from the presenter’s personal experience. If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this course is a must for you.

Learning Objectives:

At the end of this webinar, the attendees will be familiar with the following:

- Most common regulatory issues for clinical trial management.
- Documents required for FDA submission and trial master files.
- Processes to seek and document management decisions with regulatory implications.
- Do's and Don'ts for regulatory management of a clinical trial.

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