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Wed, Nov 18, 2009 9:00am		REGULATORY BASICS by HALLORAN Consulting Group - Course / Training / Workshop (Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110) This course is designed for pharmaceutical and biotech professionals responsible for regulatory strategy and operations. It will teach the essentials of regulatory project management, with a focus on how these skills can be applied in the process of creating an initial Investigational New Drug (IND) application. Through the use of lectures, discussions and case studies, participants will learn about the key elements of the regulatory process in the United States, discuss the required elements of an IND, the utility of the Clinical Trials Directive (CTD) for building a foundation for continued development and other key topics. Who will benefit: This course will be beneficial to those new to regulatory affairs as well as those with regulatory experience but limited exposure to the early phases of development stage work in the pharmaceutical and biotech industries. Managers who are not versed in regulatory, but are involved with clinical trial programs will also benefit. Key topics: * What is an IND? * The Pre-IND Meeting - Dos and Don'ts * What is FDA looking for in the initial application * Is the CTD an option? * Timeline management * Submission and post submission success Learning Outcomes: * Understanding of the IND process and key decision points * Understanding of how regulatory strategy drives decisions in the drug development process * Recognition of regulatory hurdles * Knowledge of how to build effective submissions * Recognition of the need to effectively manage expectations and timelines For all public and customized training offered by HALLORAN, please visit: http://www.hallorancg.com/training/index.php
Thu, Nov 19, 2009		European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009		European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Mon, Jan 11, 2010		Advancing Biologics from the lab to the clinic - Conference (Brussels, Belgium) This event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies .
Tue, Jan 12, 2010		Advancing Biologics from the lab to the clinic - Conference (Brussels, Belgium) This event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies .

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