REGULATORY AFFAIRS

DOWNLOAD AGENDA

 

 

Regulatory Affairs, Wednesday 20 March 2019

08:45

Organiser’s welcome Remarks

08:50

Chairman’s opening Remarks

09:00

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.
Nadia Suttikulpanich
09:20

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

10:20

Roundtable discussion

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

Table 2 Fostering commercial partnerships to tap on emerging APAC markets

Table 3 Regulatory collaboration and opportunities in more efficient drug development

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

Table 5 Universal healthcare- Is it really costly?

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

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

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?

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

Kum Cheun Wong
Regulatory Affairs
12:00

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

Handsome Ji
Regulatory Affairs
12:20

Digital intervention in streamlining regulatory publishing & submission activities

13:00

Exhibition Visit & Networking Lunch

INNOVATIVE NEW DRUG REGISTRATION

Crystal Sun
Regulatory Affairs
14:30

CAR-T therapy regulation requirement in China

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

COMPLIANCE

Mario Bertazzoli
Regulatory Affairs
15:30

The role of pharmacovigilance in ensuring health product safety

Sam Shen
Regulatory Affairs
15:50

Quality Management System of CAR-T cell therapy

Regulatory Affairs
16:10

New compliance rules and what companies need to consider

16:30

End of Phar-East 2019

last published: 26/Sep/18 03:35

 

 

DOWNLOAD PROSPECTUS

 

 

For speaking, sponsorship and exhibition opportunities contact jonathan.mottram@terrapinn.com
Tel: +65 6322 2738