Why Should You Attend:
The South East Asian markets are growing in importance and interest in access to innovative products. In-country regulatory agencies are progressing in their sophistication, process development and regulatory requirements.
Note: Japan & South Korea are not covered as they are the subject of popular companion courses entitled: South Korea: Navigating the Regulatory and Clinical Trial Environment and Japan: Navigating the Regulatory and Clinical Trial Environment
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in listed South East Asian Countries. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products as an importer into South East Asia. It will provide training on:
Areas Covered in this Webinar:
Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand
Who Will Benefit:
This course will be beneficial to the following personnel in Pharmaceuticals, Medical Devices, and Combination Products manufacturing companies:
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.
Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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