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Do you work in the healthcare and life sciences realm? DIA has a course for you! With the busy professional in mind, DIA has developed numerous training courses with experienced instructors to meet all your learning needs. See below for upcoming courses to help broaden your knowledge and allow you to bring back new information to your day-to-day job functions.
Regulatory Affairs: The IND, NDA, and Post-Marketing
August 13-16 | Boston, MA
October 22-25 | Philadelphia, PA
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy. This comprehensive course employs a blend of real-world examples, interactive sessions, workshops, and online pre-course modules.
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Drug Safety and Pharmacovigilance Across the Product Lifecycle
August 13-15 | Boston, MA
October 22-24 | Philadelphia, PA
Through interactive sessions and hands-on workshops, learn contemporary principles, regulatory expectations, and practical approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with a focus on the US and EU. Topics will span the lifecycle of traditional innovative medicinal products, from first-in-human through the post-marketing phase.
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New Drug Product Development and Lifecycle Management
August 13-14 | Boston, MA
Gain a better understanding of how companies structure their efforts and utilize their resources to improve the odds of successful development and minimize the risks associated with shepherding a new drug candidate through the development process. Explore the various phases of drug development, major work streams, key players, and interrelationships necessary to develop new drugs in the US and EU and to expand the lifecycle of in-line products.
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Clinical Statistics for Nonstatisticians
August 13-14 | Boston, MA
Increase your level of statistical knowledge by focusing on topics such as confidence intervals, hypothesis testing, trial designs, and methods for establishing non-inferiority and equivalence.
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Advanced Signal Detection – Tools, Triage, Evaluation, and Escalation
August 16-17 | Boston, MA
This course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on practical exercises and discussions. Learn about the new sponsor obligations for signal detection in EudraVigilance based on updates to GVP Module IX.
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NEW! The Pharmacovigilance Quality Management System
September 26-27 | Washington, DC
Explore the organizational structure, responsibilities, processes, and resources required for the pharmacovigilance system and its quality system. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.
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Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets
October 1-2 | Washington, DC
Receive practical, real-world, and actionable information on the nature and development of global regulatory strategies for drug development, with a focus on markets located outside the US including Europe, Asia-Pacific, Latin America, Africa, and other emerging markets.
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NEW! Regulatory Affairs for Combination Products
October 17-18 | Washington, DC
Learn about FDA's approach to regulation of combination products including FDA's recent guidance. Discuss the processes to streamline and integrate development of single entity, co-packaged and cross-labeled products, as well as approaches to aligning requirements between drugs and devices and assuring successful human factors interface.
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