Pharmaceutical Regulatory Affairs – Agenda

Programme timing and speakers may change based on market development.
All timings are in SGT (UTC +8). Click here to convert to your timezone »

Day 1: 23 September 2020 | Wednesday

13:00
KEYNOTE ADDRESS:
From Cancer to COVID-19: Balancing Short & Long Term Corporate Goals, Engaging in New Collaborations & Building the Future of Digital Pharma

Dr. Andreas Schmidt, Chief Executive Officer, Proteona, Singapore/Germany

13:30
PHARMA LEADERS’ THINK-TANK:
Redefining Pharma’s Role in the Global Healthcare Reform Agenda

  • COVID-19 vaccines candidate development
  • Regulations on pandemic drugs approval and accelerated clinical trials under diverse regimes
  • Future of pricing and affordability for Novel Drugs
  • Why technology should be the key component to surviving COVID-19?
  • AI and its immense potential in use of pandemic treatments and early detection

Moderator:
Christine Kuan, Board Director, Taiwan Cognitive Enhancement Association, Taiwan

Panelists:
Dr. Sucharita Das, Chief Consultant Regulatory, Quality and Clinical Trials Global/ APAC, Singapore
Edsel Pereira, Group Vice President – Information Technology, Glenmark Pharmaceuticals, India
Alexander Zach, Senior Vice President, Global Head of Market Access and Policy, Biocon, India
Dr. Keith Carpenter, A*STAR Senior Fellow, Pharma Innovation Programme Singapore (PIPs), Singapore

14:30
Online Networking & Stretch Break


13th Annual Pharma Regulatory Affairs Commences

REGULATORY PRIORITIES POST COVID-19 


15:00
Chairperson’s Opening Remarks

Shun Jin, Head Regulatory Affairs EMA, Sandoz Asia Pacific, Singapore

15:10
Regulatory Affairs Priority Setting:

Speed and Flexibility for Drug Approval During and After COVID-19

  • Regulatory priorities for department and wider company
  • Better and efficient engagement with Authorities for speed to market authorisation plans – Benchmarking globally
  • Working well with anticipated regulatory changes post COVID-19
  • Regulatory update of drug development on Covid-19

Moderator:
Shun Jin, Head Regulatory Affairs EMA, Sandoz Asia Pacific, Singapore

Panelist:
Aziza Ahmed, Director, APAC CMC Regulatory Affairs, MSD International GMBH, Singapore
Joelle Chia, Co-Director, Pharma To Market, Singapore
Lakshmi Kanth Maddela, Head of Drug Regulatory Affairs, Daewoong Pharmaceutical, India


COVID-19: REGULATORY FEXIBILTY AND DEVELOPMENTS


16:00
Key Steps to Take When Inspections Go Wrong

Dr. Sucharita Das, Chief Consultant Regulatory, Quality and Clinical Trials Global/ APAC, Singapore

16:30
Comparisons of CMC Variations in the Region & Managing Complications

  • Requirements and challenges in design and change in manufacturing process and product specifications
  • Stability studies
  • Similarities and differences with post approval changes in ASEAN/US/EU
  • How these CMC processes and issues relate to the product’s regulatory strategy

Aziza Ahmed, Director, APAC CMC Regulatory Affairs, MSD International GMBH, Singapore

17:10
End of the Digital Conference Day 1

Day 2: 24 September 2020 | Thursday


PRICING, PRODUCTS AND REGULATIONS


13:00
Chairperson’s Opening Remarks

Pakhi Rusia, Former Director, Global Regulatory Affairs, GlaxoSmithKline Consumer Healthcare, Singapore

13:00
Generics, Biosimilars, Combination Therapies and Biologics

  • Global development update for biologic products
  • Overview of the registration procedure and approval process for both generics and biosimilars in Asia
  • Pricing mechanisms
  • Commercialisation risk during COVID-19 pandemic

Pakhi Rusia, Former Director, Global Regulatory Affairs, GlaxoSmithKline Consumer Healthcare, Singapore

13:40
The Update on the New Price Control Implementation in the Philippines

  • Are price controls the solution to expensive drugs?
  • The update on the new retail price regulation
  • Long-term investment impact in the Philippines’s pharma industry
  • Strategy to manage the cost containment

Catherine Clemente, Associate Lead, Drug Regulatory Affairs & Pharmacovigilance, Sandoz, Philippines

14:20
Online Networking & Stretch Break


COVID-19: REGULATORY FEXIBILTY AND DEVELOPMENTS


15:00
Incorporating Asia into MRCTs: Promoting Benefits and Overcoming Challenges

  • How do you present the advantages Asia offers to Sponsor’s from outside the region?
  • How do you help those outside the region overcome their perceived challenges?
  • What impact might Covid have?

Peter A Moteram, Director, ProActive Study Management, UK

15:40
Knowledge Session:
Regulatory Submissions Guidance:

  • Working with various regulatory agencies during Covid-19
  • Case Study from India or other countries

Lakshmi Kanth Maddela, Head of Drug Regulatory Affairs, Daewoong Pharmaceutical, India

16:20
Streamlining global submission conversions for regional markets

  • Cloning a core eCTD dossier for other regions
  • Re-use and transformation between different formats
  • Tips for streamlining publishing processes
  • Developing conversion strategies to gain efficiencies in submission preparation

Daria Wain, Regulatory Publishing Specialist & Trainer, Pharma To Market, Australia

17:00
End of Digital Conference Day 2

Day 3: 25 September 2020 | Friday


DIGITALLY TRANSFORMED REG AFFAIRS


13:00
Chairperson’s Opening Remarks

Daria Wain, Regulatory Publishing Specialist & Trainer, Pharma To Market, Australia

13:00
Digital Transformation and Regulatory Needs

  • Regulatory developments to support the digitalization of pharma
  • Challenges, opportunity, and benefit
  • Pharma digitalization implementation in Thailand

Phusit Prakongsai, Acting Senior Advisor on Health Promotion, Office of Permanent Secretary, Ministry of Public Health Thailand, Thailand

13:40
International eCTD Implementation and Examining the Common Pitfalls

  • Timelines, scope and pros and cons in Asia
  • Assessing the status of eCTD v4.0
  • Successful case study of eCTD implementation
  • An update on eSubmission in China

Sophia Huang, Regional Group Head, Regulatory Submission Management, Bayer, China

14:20
Online Networking & Stretch Break

15:00
E-Retail Regulatory Updates:
E-Commerce and Consumer Healthcare

  • eCommerce and Healthcare
  • ASEAN regulations on ePharmacy and medicinal products
  • Regulatory and enforcement challenges

Woei Lee Chen, Head of Regulatory Affairs, Reckitt Benckiser, Singapore

15:40
Assessing GDPR and Data Protection Compliance in Pharma

  • Understanding data protection laws and regulation
  • Key strategies to apply them into Asia
  • How to manage the implied risk?

Sebastian Handorf, Senior Legal Consultant, Compliance & Data Privacy, Astracrux, Philippines


JOINT CLOSING PLENARY SESSION


16:20
DIVERSITY AND INCLUSION ROUNDTABLE:
Cultivating the Next-Gen of Women Leaders in Pharma

  • Why does gender equality matter on the board?
  • Key challenges facing women leaders in Pharma
  • Management efforts to address some of these challenges, and remaining gaps
  • Reflections on the journey to the top
  • Breaking the glass ceiling: Lessons learnt along the way, and advice to my younger self
  • Management efforts to address some of these challenges, and remaining gaps

Panelists:
Anupama Rao Singh, Director, Oncology and Hospital CoE, Global Generics, Emerging Markets, Dr. Reddy’s Laboratories, India
Angela Brady, Director of Innovation Research, APAC R&D, GSK, Singapore
Chandana Yeluri, Head- Digital and Continuous Improvement, Sandoz Development Center, Novartis, India

17:10
End of Digital Conference Day 3