The objective of this workshop is to provide participants with a comprehensive understanding of the importance and underlying principles of Chemistry, Manufacturing, and Controls (CMC) requirements from a regulatory perspective. Attendees will gain in-depth knowledge of the CMC section of the Common Technical Document (CTD), the required format for regulatory submissions in Canada and the EU. This workshop will equip participants with the skills needed to effectively compile and present CMC data, ensuring compliance with regulatory standards and facilitating successful submissions.
This workshop is tailored for professionals involved in regulatory affairs, quality assurance, and product development within the pharmaceutical and biopharmaceutical industries. It is particularly beneficial for those responsible for compiling and submitting CMC data, including regulatory submission specialists, technical writers, project managers, and quality control personnel. Additionally, consultants and other stakeholders engaged in the preparation of regulatory submissions will find this workshop invaluable for understanding and meeting CMC requirements.
This workshop covers the following topics:
Gain a thorough understanding of the role and importance of Chemistry, Manufacturing, and Controls (CMC) in the drug development process, ensuring regulatory compliance and product quality.
Mastery of Analytical Methods and ValidationDevelop proficiency in selecting and validating analytical methods, as well as characterizing drug substances and products to meet regulatory standards.
Expertise in Manufacturing and Process ValidationLearn best practices for manufacturing processes, in-process controls, and process validation, including the development of robust drug product specifications.
Proficient in Regulatory Submissions and Stability TestingAcquire skills in preparing the CMC section of regulatory submissions, understanding the structure and components, and conducting stability testing to determine acceptable changes and ensure product integrity.
All participants will receive a certificate of attendance upon completion of the workshop.
Note: Registration closes one week prior to the start of workshop.
AAPS
Instructor
Ronald’s journey in pharmaceutical Regulatory Affairs has been 20 years of work experience that started in the Innovative area back in 2003 under ApoPharma Inc. (now known as Chiesi Canada Corp.) working on new registration applications (NDA and NDS) with a focus on the clinical sections of the dossier. He then moved to become a Senior Regulatory Affairs Manager in the Generics area under Apotex Inc. in 2007 where he managed a large portfolio of marketed products focusing on regulatory change assessments and submissions for global markets including Canada, US, EU, Australia and other international markets. The focus of his work at Apotex Inc. is on the preparation and maintenance of Module 3 (Quality or CMC) of the submission dossier. While working in the industry, Ronald joined as a RA program instructor for the Academy of Applied Pharmaceutical Sciences (AAPS) in 2021.
Ronald has studied Medicine for 2 years after completing a 4 year Bachelor’s of Science program in Life Sciences that majored in Biology in the Philippines. Upon moving to Canada, he enrolled in Humber College and completed their Post-Graduate Certificate RA program where he graduated with Honors. Shortly thereafter, he also took the Regulatory Affairs Certification (RAC) exam for Canada from the Regulatory Affairs Professionals Society (RAPS). Regulatory Affairs has given him a thorough insight of the pharmaceutical landscape that has allowed him to impart his knowledge to others who are greatly interested in this field.
