Biosimilars Workshop

  • DATE & TIME

    30 August 2016 - 02 September 2016
    08:30am - 06:00pm

  • PLACE

    Duke-NUS Medical School; Lead on 3 Room #03-16 Level 3

  • Contact

    CoRE@duke-nus.edu.sg or +65 6601 5541

ABOUT THE EVENT

Biosimilars Workshop

In the past decade, biosimilars have gained traction in the pharmaceutical market. With the entry and rise of biosimilars, it is important that regulatory professionals are equipped with the necessary knowledge and skills to evaluate the quality, safety, and efficacy of such health products.
 
To access presentation materials from this workshop, please click on the individual speaker’s name below 
          

10% discount for groups of 5 or more.
  
10% discount for CoRE Contributors.
  
All prices are inclusive of GST.
   
All prices in SGD.

Speakers of the event

A/Prof John Lim

Executive Director, CoRE
Deputy Director of Medical Services (Industries & Research Matters),
Ministry of Health, Singapore

Dr Kenji Sawanobori

Reviewer,
Office of Cellular and Tissue-based Products,
PMDA

 

Dr Yasuhiro Kishioka

Principal Reviewer,
Office of Cellular and Tissue-based Products,
PMDA

Dr Charu Manaktala

Senior Medical Director & Head of Asia Pacific Biosimilars Centre of Excellence
Head of Clinical Strategy
Strategic Drug Development- Asia
Quintiles

 

Ms Agnes Chan

Director (Clinical)
Therapeutic Products Branch
Director
Scientific Advisory Office
Health Sciences Authority

Dr Toh Ding Fung

Regulatory Specialist
Therapeutic Products Branch
Health Sciences Authority

 

Dr Anne Cook

Biologicals Quality Assessor
Licensing Division
Medicines and Healthcare products Regulatory Agency

Dr Kevin Grant

Biochemistry Section
Laboratories Branch
Medical Devices and Product Quality Division
Therapeutic Goods Administration

 

Dr Sundar Ramanan

Director
Global Biosimilars Policy
Regulatory Affairs
Amgen
International Federation of Pharmaceutical Manufacturers & Associations

Dr Sannie Chong

Head
APAC Technical Regulatory Policy
Genentech
Roche

 

Dr Sivabalan Sivanesan

Regional Medical Leader
Roche

Dr Eva Mardomingo Santas

Quality Site Head
Head of Lot Disposition
RSTO
Roche Pharmaceuticals

 

Dr Ning Li

VP
Head of Asia Regulatory and Medical Policy
Sanofi
Beijing, China

Dr Ralf Herbold

Director
Global Regulatory Affairs CMC & Devices
Biologics
Sanofi
Frankfurt, Germany

 

Dr Gillian Woollett

Senior Vice President
Head, FDA Policy and Regulatory Strategy Practice
Avalere Health

Dr. Sreedhar Sagi

Head of Medical Affairs Asia-Pacific
Sandoz Biopharmaeuticals
Novartis Asia Pacific Pharmaceuticals