REGULATORY AFFAIRS
 

 

Regulatory Affairs, 2019年3月20日(三)

08:45

Organiser's welcome Remarks

08:50

Chairman's opening Remarks

Nadia Suttikulpanich
09:00

Disrupt before being disrupted: Using digital tech to connect to previously uneconomic chronic disease customers

Insurance is a tricky part of healthcare business. Increased healthcare costs lead to a higher profit for pharma and provider companies but burdens the government budget and hurts the insurance business. Since taking care of a chronic patient is a lifelong commitment, the availability of insurance to cover this essential treatment is often expensive and uneconomical. Join Nadia Suttikulpanich, Head of the Fuchsia Innovation Center, part of Muang Thai Life Assurance, Thailand as she shares how they are adopting digital tech to pilot chronic disease cover to provide for patients in need while keeping their insurance business profitable.
Nadia Suttikulpanich, Head Of Fuchsia Innovation Center For Muang Thai Life Assurance, Muang Thai Life Assurance Public Company
Edward Rosen
09:20

The path to personalised medicine: Key developments

Everyone knows the potential benefits of personalised medicine, but how do we get there? Finding and better defining disease through biomarkers and more accurate diagnostics. Targeted therapeutics to leverage new and emerging diagnostic capabilities. Personalized Medicine to Real-Time Medicine. How to drive success across industry and clinical implementation in an economic manner. This presentation discusses various strategies and key considerations to drive the symbiosis between academia, industry and clinical medicine to drive vastly improved patient outcomes.
Edward Rosen, Leader, Glendevon Life Sciences LLC & Executive in Residence, Columbia Technology Ventures
Panel discussion
09:40

Pharma 4:0 Digital disruption: New players, new opportunities

Moderator: Shwen Gwee, General Manager, Digital Accelerator (Global Drug Development), Novartis
Teck Jack Tan, Chairman And Medical Director, Northeast Medical Group
Matt Cooper, Business Development And Research Director, NIHR Clinical Research Network
Andreas Koester, Vice President Of Clinical Trial Innovation And External Alliances, Johnson & Johnson
David Benshoof Klein, Chief Executive Officer, Click Therapeutics
Raghu Bathina, Founder, Future World Studios
10:20

Roundtable discussion

Table 1 Working with clinical outsourcing partners: Risk management and prevention

Pei Yin Tan, Director, Asia Clinical Operations, Medicine Development Center, Eisai Clinical Research Singapore Pte Ltd

Table 2 Fostering commercial partnerships to tap on emerging APAC markets

Charles Stacey, President And Chief Executive Officer, Cerecin

Table 3 Regulatory collaboration and opportunities in more efficient drug development

Phusit Prakongsai, Ministry of Public Health Thailand

Table 4 Strategies in making drugs more affordable and accessible to patients in developing countries

Pratapa Satyanarayana, Former Senior Director And Group Country Head, Dr. Reddy?s Laboratories Ltd.

Table 5 Universal healthcare- Is it really costly?

Table 6 A convergent approach: Tapping on western expertise to serve Asia population

Philippe Pinton, Regional Head, Specialty Therapy, Takeda

Table 7 Precision to personalised medicine- How do we get there?

Mrunalini Jagtap, Data Management Lead, SICS, A*STAR

Table 8 Leveraging blockchain technology in making clinical trials more transparent and efficient

Table 9: Data Science in practice: How can sales reps and MSLs use Big Data?

Prabhuram Krishnan, South Asia Medical Director, Ipsen Pharma

Table 10: The Singapore biotech ecosystem - What comes after the Inflexion?

11:00

Exhibition Visit & Networking Refreshments

REGIONAL REGULATORY PARTNERSHIP

Vicky Han
Regulatory Affairs
11:40

Convergence, harmonisation and collaboration: The evolution of Asia's pharma regulatory landscape

Vicky Han, Senior Director, Regulatory Policy Group Lead For Asia Pacific, Janssen Pharmaceuticals
Kum Cheun Wong
Regulatory Affairs
12:00

Challenges, opportunities and partnerships in the ASEAN pharma industry: A regulatory perspective

Kum Cheun Wong, Head Asia Pacific Policy And Liaison, Drug Regulatory Affairs, Novartis Asia Pacific
Handsome Ji
Regulatory Affairs
12:20

Digital intervention in streamlining regulatory publishing & submission activities

Handsome Ji, Apac Publishing Lead, Pfizer China
Xin Du
Regulatory Affairs
12:40

Stakeholder management in regulatory affairs: A case study

Xin Du, Senior Vice President And Head Of Global Regulatory Affairs, Adlai Nortye Biopharma
13:00

Exhibition Visit & Networking Lunch

INNOVATIVE NEW DRUG REGISTRATION

Crystal Sun
Regulatory Affairs
14:30

CAR-T therapy regulation requirement in China

Crystal Sun, Chief Executive Officer Assistant And Director, Regulatory And Government Affairs, Fosun Kite Biotechnology
Panel discussion
Regulatory Affairs
14:50

Expedited review pathways in North East Asia and what it means for APAC stakeholders

  • Priority review and reform for new product launches in China
  • Latest updates on Good registration management (GRM) and approval pathways in Japan, Korea, Taiwan
  • Opportunities to expand to greater Asia and lessons for the rest of Asia
Handsome Ji, Apac Publishing Lead, Pfizer China
Finny Liu, Apac Regional Regulatory Policy Lead, Roche

COMPLIANCE

Mario Bertazzoli
Regulatory Affairs
15:30

The role of pharmacovigilance in ensuring health product safety

Mario Bertazzoli, Director, Group Head Of Drug Safety, Helsinn SA
Sam Shen
Regulatory Affairs
15:50

Quality Management System of CAR-T cell therapy

Sam Shen, Qa Director, Fosun Kite Biotechnology
Yuliana Indriati
Regulatory Affairs
16:10

Regulatory compliance in biologic products comparability following technology transfer

Yuliana Indriati, President Director, Pt. Kalbe Genexine Biologics
16:30

End of Phar-East 2019

last published: 17/Jan/19 09:15

* 活動內容有可能不事先告知作更動及調整。