With 20 years’ experience in regulatory affairs and strategy, Sannie's initial career was with the Singapore Agency for 10+ years. She represented Singapore in the WHO prequalification program, the ASEAN Pharmaceutical Products Working Group, and the Australia-Canada-Singapore-Switzerland (ACSS) Consortium for work-sharing initiatives. In 2014, she accepted a role with Roche as Asia Pacific (AP) Regulatory Policy Lead. There, she expedited patients’ access by tracking KPIs of regulators’ convergence in APEC, and co-championing the APEC biotherapeutics work areas on behalf of the BIO coalition. Sannie continues to drive an efficient and sustainable regulatory environment that is powered by digital transformation.

James is in charge of identifying the educational needs for the various stakeholders involved in regulatory affairs in the Asia Pacific region, and establishing education roadmaps, priorities and deliverables. In this role, he actively conducts discussions with regulatory affairs professionals across Asia Pacific, and develops training workshops to enhance regulatory competencies, He is involved in regional and global initiatives for regulatory systems strengthening. James draws his experiences as a regulator in Singapore’s Health Sciences Authority, hospital pharmacist, and his PhD on benefit-risk decisions and innovation in regulatory affairs.

Isabel is a Regional Dossier Publisher focusing on publishing submissions in various formats, including eCTD, and providing technical consultation for AP countries who have implemented eCTD or actively planning towards eCTD implementation. Isabel holds a bachelor’s degree in Pharmacy from National University of Singapore.

Felicity completed a PhD in natural product synthesis at the ANU and then took up a role at Singapore’s Institute of Chemical and Engineering Sciences. Felicity then joined the TGA as a Pharmaceutical Chemist and has experience with new generic medicines and variations. Felicity has broad knowledge of the regulation of prescription medicines and has led teams responsible for: case management, confidence building with other regulators, external evaluator procurement, Industry Working Groups, AusPARs, expert advisory committees, FOI, media and ministerial responses and business reforms. She has recruited a team which builds on the achievements of the past five years and reaffirms Australia’s support for regional regulators.

Dr Karen Loft is a chemist by training, obtaining a PhD in Organic Chemistry at the University of Melbourne. Prior to joining the TGA, she spent a number of years in medicinal chemistry research. Karen has over 10 years’ experience at the TGA in the areas of pharmaceutical chemistry evaluation (new registrations and variations), including products manufactured using advanced processes, as well as Risk Management Plan assessment. Karen now works in the Regulatory Strengthening Program, providing technical assistance to countries across Southeast Asia and the Pacific.

Kristiina Puusaari is an eSubmission coordinator at the European Medicines Agency (EMA) working on Programme and Project Management for electronic submission systems and projects, such as eCTD, EMA eSubmission Gateway, electronic Application Form (eAF), Common Repository, PSUR Repository and the Single Submission Portal. Kristiina is the business domain expert for the EMA eSubmission systems as well as the Chair of the eSubmission Change Management Board. Kristiina also represents EMA in the ICH M8 IGW/EGW.

Jia-Ying Chuang, also known as Leon has been working for 12 years at Taiwan FDA (TFDA), His focus is on import licenses and Taiwan's ECTD business. At TFDA, he ensures safe and quality pharmaceutical products, prioritizing compliance. His major contribution has been in ECTD implementation.

Lim Boon Kian graduated from the National University of Singapore and began her career in HSA as a project manager handling full dossier applications. She has taken on different job functions in the branch and is now leading the regulatory support team in product registration, post-approval variations and product life-cycle management.

Rakesh Neelam is a highly accomplished and dedicated regulatory professional certified by RAPS, with 10 years of experience in Regulatory eCTD submission management, Rakesh is currently working as a Regulatory Submission Specialist at MSD Pharmaceuticals.