Events
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The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 04/02/2012 5:00 pm
End: 07/24/2012 4:30 pm
Learn more: www.practicepaysolutions.com/mastery Join us for a free series of one-hour webinars with the a team of industry experts! We're presenting the less-covered, critical issues for small business owners, so you can reduce the time you spend on set-up and administration-- and focus on what really matters. Can't attend live? We'll send you the call recordings so you can access valuable information and share the event with your community! April 2nd: The Joy of Productivity with George Kao April 16th: How to Create Profitable Referral Partnerships with Robert Notter April 24th: Say Bye-Bye to Your Boring Bio with Nancy Juetten May 15th: From Contacts to Contracts with Caterina Rando May 22nd: Red Fire Profitability with Liz Goodgold June 5th: Developing Contracts & Service Agreements with Tasha Cooper Coleman June 19th: Outsourcing Secrets with Travis Greenlee July 10th: Your Money Relationship = Your Business Success with Helen Kim July 24th: How to Play a Bigger Marketing Game with Fabienne Fredrickson Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit. Start: 07/24/2012 10:00 am
End: 07/24/2012 11:30 am
Why Should You Attend: Change in control agreements between companies and executives, so-called “golden parachute agreements,” have become a ubiquitous part of the executive compensation scene for both public and privately held companies. However, tax code and federal securities law requirements, investor and media scrutiny, and potentially high stakes litigation make the development and implementation of golden parachute plans and agreements one of the most important parts of the compensation process. This session will show how careful drafting and tax planning of golden parachute plans and agreements can help avoid undue scrutiny and criticism, that will benefit both the company and the covered executive. At the end of this training, participants will have gained the knowledge and understanding necessary to develop and implement golden parachute agreements and provisions that are more acceptable to the Government, investors, buyers, the media and others. Areas Covered in the Seminar: - Code Sec. 280G and Code Sec. 4999. Start: 07/24/2012 10:00 am
End: 07/24/2012 11:00 am
Description The introduction of new drugs and the ongoing researches on therapies directed at critical molecular targets have caused several difficulties among Medical Oncologists and as well as among Companies and CRO. More than 80% of drugs for all indications entering clinical development do not get marketing approval, with many failing late in development often in Phase III trials, because of unexpected safety issues or difficulty determining efficacy, including confounded outcomes. A critical point is related to the clinical trial conduction within the sites. For the above mentioned reasons, it is important to know what deviations, violations and exceptions represent and when they could have an impact on the clinical trial results. Areas Covered in the Seminar: - Traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints…) Start: 07/24/2012 10:00 am
End: 07/24/2012 11:00 am
Description Why Should You Attend: More than ever, the business community perceives the need not only to articulate the principles of good governance, compliance, risk management, and ethics — but also to integrate these concepts into the fabric of day-to-day business — and use them to drive better performance. An effective internal audit function is a valuable resource for management, the board and audit committee due to its understanding of the organization and its culture, operations, and risk profile. The objectivity, skills, and knowledge of competent internal auditors can contribute to the effectiveness of an organization's internal control, risk management, and other governance processes. An internal audit of a GRC program will assist in improving the governance practices of your organization.
Start: 07/24/2012 10:00 am
End: 07/24/2012 11:30 am
Description This webinar will start off with a discussion on the thermal properties of a formulated product and how stabilizing excipients can affect these (the first step in any well designed and understood process and formulation). Next, the discussion will turn towards understanding the different types of biologically based products commonly encountered in modern pharmaceutical and diagnostic markets, and the problems with long term stability. The mechanisms and process of stabilization through targeted stabilizing excipients and lyophilization will be covered in great detail, in addition to understanding the analytical techniques used to develop and verify a suitable formulation and process. Finally, the session will finish with a discussion on formulation and stabilization techniques for cells and viruses, which pose a very large challenge for the formulation and process development scientist. Learning Objectives: Principles of biomolecule stabilization. Start: 07/24/2012 10:00 am
End: 07/24/2012 11:00 am
Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing. API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm. Why Should You Attend: Attending this webinar will help you identify what you need to know and examine during an audit of your CMO or API suppliers. The webinar leader will help you identify key regulatory and industrial issues associated with API manufacturing. You are purchasing more than a chemical or biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. While understanding the applicable GMP is important, how to apply the GMP and what to establish with a CMO is critical to your supply chain. Areas Covered in the Session: Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself. Start: 07/24/2012 10:00 am
End: 07/24/2012 11:00 am
Overview: The ICH guideline on Validation of Analytical Procedures (Q2R1) delineates the guidance and methodology for validation characteristics of an analytical procedure. Like most guidelines, the terminology is vague enough to allow for several acceptable approaches and analysis. Appropriate statistical methods should be used and all relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. A statistical approach to validation of analytical methods can minimize the amount of testing while meeting the requirements of the guideline. Areas Covered in the Session: Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. Price List: | ||
