REGULATORY AFFAIRS

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Regulatory Affairs, Wednesday 20 March 2019

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.
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.
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 - Enhancing patient engagement in clinical trials

Table 5 - Futureproofing the workforce and leveraging the sharing economy in your business

Table 6 - Precision to personalised medecine: How do we get there?

Table 7 - Outsourcing your injectable: Benefit from an experienced CDMO partner

11:00

Exhibition Visit & Networking Refreshments

REGIONAL REGULATORY PARTNERSHIPS

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

Xin Du
Regulatory Affairs
12:40

Stakeholder management in regulatory affairs: A case study

13:00

Exhibition Visit & Networking Lunch

INNOVATIVE NEW DRUG REGISTRATION

Panel discussion
Regulatory Affairs
14:30

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

Yuliana Indriati
Regulatory Affairs
15:50

Regulatory compliance in biologic products comparability following technology transfer

16:10

End of Phar-East 2019

last published: 18/Mar/19 14:05

 

 

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