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In August 2019, the Revised Drug Administration Law (DAL) was published by the Chinese State Council (effective from Jan 2020) followed by the release of the new Drug Registration Regulation (DRR) in January 2020 (effective from Jul 2020). These two publications are milestones in the fundamental changes that have taken place in China since August 2015, with the initiation of deeper reform of drug development and approval polices. They provide the framework for all new drug development and drug registration in China.
This session will introduce the official institutions governing drug development and registration in China and a detailed overview of the requirements laid out in the revised DAL and new DRR for the development of pharmaceutical products. Content will provide you with best practices for approaching the new regulatory environment, as well as critical points where the landscape has changed. Additionally, you will learn from recent case studies on potential regulatory pathways leading to new imported and local drug registration in China.
At the completion of this session, you will be able to:
*Summarize the legal framework and government institutions involved in drug development and new drug registration in China
*Interpret requirements laid out in the DAL and DRR for conducting drug development in China
*Identify requirements and process for registration of imported and local drug registration in China
This course will be of benefit any company personal involved in planning and execution of drug development and drug registration in China.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries. He also has consulted to government agencies from the United States, the Royal Government of Saudi Arabia, Canada, Cayman Islands and the United Kingdom.
He has published numerous articles in the fields of surviving mergers and acquisitions, surviving change, project management, management, sales, team-building, leadership, ethics, customer service, diversity and work-life balance, in publications ranging from ASTD/Performance In Practice to Customer Service Management. His book, “90 Days to a High-Performance Team”, published by McGraw Hill has helped help executives, managers and team leaders improve performance. Mr DeVany has also been interviewed for various radio and television programs.
He has appeared hundreds of times on radio and television interview programs to discuss mergers and acquisitions (how to manage and survive them), project management, sales, customer service, effective workplace communication, management, handling rapid personal and organizational change and other topical business issues. He has served or is currently serving as a board member of the International Association of Facilitators, Sales and Marketing Executives International, American Management Association, American Society of Training and Development, Institute of Management Consultants, American Society of Association Executives, Meeting Professionals International and National Speakers Association. Chris is an award-winning Toastmaster’s International Competition speaker. He recently participated in the Fortune 500 Annual Management Forum as a speaker, panelist and seminar leader.
Chris has distinguished himself professionally by serving multiple corporations as manager and trainer of sales, operations, project management, IT, customer service and marketing professionals. Included among those business leaders are Prudential Insurance, Sprint, BayBank (now part of Bank of America), US Health Care and Marriott Corporation. He has assisted these organizations in mergers and acquisitions, facilitating post-merger and acquisition integration, developing project management, sales, customer service and marketing strategies, organizing inbound and outbound call center programs, training and development of management and new hires, and fostering corporate growth through creative change and innovation initiatives.
Chris holds degrees in management studies and organizational behavior from Boston University. He has traveled to 22 countries and 47 states in the course of his career.