REGULATORY AFFAIRS

Regulatory Affairs, Friday 2 March 2018

09:00

Organiser's Welcome Remarks

09:05

Chair's Opening Remarks

Disruption & Digitalisation

09:10

Pharma 4.0: How digitisation & disruption are creating a need for agility and entrepreneurship in pharma

Digitisation is changing the way pharma interacts with payers, doctors and patients, leading pharma to seek out different skills and personality traits in employees. The challenge is selecting the right disruptor to foster a forward-thinking organisation, and identifying the suitable digital strategy whilst also complying with local regulations and continuing to invest in core R&D capabilities. Hear from big pharma on how they are moving forward and embracing the digital disruption.
 
09:30

CAR-T therapy, the next miracle drug in the making

Recently raised to fame as the new miracle method to treat even the most stubborn cancer cases, CAR-T trials have proven to save patients who have failed all known treatment. However, the rapid advances still stir fears about the safety of the drug after failed cases and deaths on some pharma sponsored trials. With more companies putting their CAR-T pipeline to test in the market, how can regulators ensure patient safety? And from a pharma perspective, what methods can they adopt to produce these highly personalised, customised treatments at scale? Even if it becomes fully approved for commercial deployment, what needs to be done to help patients afford the sky high cost of immunotherapy?
 
Ivor Lim
09:50

Working with increasingly informed and empowered patients in the digital ageEducated guesses, lofty aspirations, hard realities

Ideas are free and to be able to catch one by the wings and bring it back to ground is a wonderful feeling indeed. For doctors, the next step is to bring this good idea into the wards for the patient’s benefit. The transition of bench research to bedside application seems very straightforward at first glance, but it is not until the first steps are taken that one realises the numerous hurdles that have to be surmounted in order to achieve this. In the best interests of the patient, this translational sequence is prescriptive and tedious, and yet it pays no heed to other essentials crucial for the translational effort to be truly successful. This presentation also shares the journey of CellResearch Corporation which 13 years to see the light at the end of the tunnel.
10:10

Exhibition Visit & Networking Refreshments

REGULATORY AFFAIRS: DRUG DEVELOPMENT

Regulatory Affairs
11:00

Chair's Opening Remarks

Panel discussion
Regulatory Affairs
11:10

Multi regional clinical trial (MRCT) harmonisation: An overview

This one hour session includes an overview presentation on MRCT in Asia, with quick 10-minute updates from Japan, Taiwan, Malaysia, Singapore and a combined 20 minutes panel session to discuss regulatory challenges from both regulator and pharma perspectives, successes so far and what can be expected in the year of 2020
 
11:00 Overview of MRCT in Asia
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
 
11:10 Japan’s latest MRCT ICH guidelines
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
11:20 Taiwan
I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
11:30 China
Gloria Wang, Executive Director, Clinical Development Just Biotherapeutics, China
 
11:40 Singapore
 
11:50 Panel: What successes have we achieved so far and how can we build a better synergy model to promote cross-country drug development?
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China

I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
Gloria Wang, Executive Director, Clinical Development, Just Biotherapeutics, China
12:10

Exhibition Visit & Networking Lunch

REAL WORLD EVIDENCE (RWE)

Regulatory Affairs
13:40

Chair's Opening Remarks

Sonika Shah
Regulatory Affairs
13:45

Evidence Based Medicine (EBM) in Asia: Latest update

  • Learning from established framework to implement RWE-supported regulatory structures in Asia
  • Exploring the increasing importance of real world evidence in seeking drug approval
  • Preserving evidence quality with the increasing volume of clinical research
  • Developing, disseminating, and implementing better evidence for better healthcare
Panel discussion
Regulatory Affairs
14:05

Panel discussion: Using Real World Evidence (RWE) to support the rational use of medicine in Asia

  • Practicality issues in using RWE in Asia
  • Challenges and opportunities of regulatory innovation for SME pharma companies
  • RWE on emerging therapeutics: Key challenges and opportunities
14:45

Exhibition Visit & Networking Refreshments

REGULATORY AFFAIRS: DRUG PRODUCTION

Regulatory Affairs
15:15

Change and risk management in Asian manufacturing settings

  • Building a harmonised pharma quality system with emphasis on product life cycle, with design space planning, quality risk management and manufacturing science
  • Understanding opportunities and challenges associated with incorporating risk management principles in quality management systems
  • Case study in Asia
Regulatory Affairs
15:35

Ensuring data integrity in manufacturing process

  • Current data integrity issue in industry and how to overcome them
  • Strategies to prevent data integrity issues from impacting global supply chain activities
  • Data integrity from regulator’s perspective
Regulatory Affairs
15:55

Regulatory perspectives in enabling life cycle quality improvement

  • Understanding the influence of organisation culture in production quality and performance
  • Building metrics to measure quality culture
  • Exploring strategies to build strong organisational quality culture

Close of Phar-East 2018

last published: 20/Nov/17 06:25