Wednesday, 10 October 2018:Programme

Regulation & Access

10 October 2018- Wednesday, 08:00-09:00: Registration

10 October 2018- Wednesday, 09:00-10:30: Plenary Session 3: Strengthening Regulatory Networks for Facilitating Access to Quality, Safe and Affordable Medical Products

Time

Plenary Session 3- Wednesday, 10 October 2018

Room

Wednesday,

9:00-10:30

Strengthening Regulatory Networks for Facilitating Access to Quality, Safe and Affordable Medical Products

Chairs: Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India;

Mr Ajay Prakash Sawhney, Secretary, Ministry of Electronics and Information Technology, Government of India

Co-chairs: Dr RK Vats, Additional Secretary, Ministry of Health and Family Welfare, Government of India;

Dr Mariângela Batista Galvão Simão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals, WHO, Switzerland

Plenary Hall

Panelists

1.      Dr Eswara Reddy, Drugs Controller General of India, Central Drug Standard Control Organization, India- Strengthening Regulatory Systems for Medical Products  in India and for Global Markets including  SEARO

2.      Dr S Leigh Verbois, Assistant Commissioner for International Programs, US FDA, USA- Strengthening the Supply Chain

3.      Dr Manisha Shridhar, Regional Advisor, WHO South-East Asia Regional Office, India- Access to Medical Products: Impact of Regulation, Trade, and Intellectual Property-Opportunities for Collaboration

4.      Mr Rishi Prakash, Joint Director, e-Governance; Ms Payal Saluja, Principal Technical Office, Centre for Development of Advanced Computing, India- Leveraging Information Sharing Platform for SEARN Countries

10 October 2018- Wednesday, 10:30-10:45: Tea Break

10 October, 2018-Wednesday, 10:45-12:15: Plenary Session 4: Global Models for High-end Manufacturing of Medical Products

Time

Plenary Session 4- Wednesday, 10 October, 2018

Room

Wednesday, 10:45-12:15

Global Models for High-end Manufacturing of Medical Products

Chairs: Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India;

Dr Balram Bhargava, Secretary, Department of Health Research,  Ministry of Science and Technology, and Director General, Indian Council for Medical Research, Government of India

Dr Indu Bhushan, Chief Executive Officer, Ayushman Bharat Programme, Government of India

Moderated By: Mr Lav Agarwal, Joint Secretary, Ministry of Health & Family Welfare, Government of India

Plenary Hall

Keynote Addresses:

·         Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India- Ideation to Commercialization of Medical Products-DBT Initiatives

·         Dr Balram Bhargava, Secretary, Department of Health Research,  Ministry of Science and Technology, and Director General, Indian Council for Medical Research, Government of India- High Tech Manufacturing for Local Healthcare Needs- Providing Adaptive Technology Solutions

Panelists

1.      Dr Poonam Malakondaiah, Special Chief Secretary, Health, Medical and Family Welfare, Government of Andhra Pradesh, India- India’s Boost to Global Manufacturing for High Tech Medical Devices and Diagnostics

2.      Dr Manisha Shridhar, Regional Advisor, WHO South-East Asia Regional Office, India; Dr Madhur Gupta, Technical Officer-Pharmaceuticals, WHO India- Fostering Local Production and Technology Transfer  for Medical Products

3.      Dr Arun Bhardwaj, Director, Central Drugs Laboratory-Kasauli, India-Quality Manufacturing to Meet National and Global Vaccine Needs

4.      Dr Rajiv Nath, Association of Indian Medical Device Industry, India- Accelerating Innovation (Faster Up-Gradation of Existing Technology and Global New Product Innovation)

10 October 2018- Wednesday, 12:15-13:30: Parallel Session 5: Standard Setting and Quality Benchmarks for Medical Devices and Diagnostics in National and Global Markets

Time

Parallel Session 5– Wednesday 10 October 2018

Room

Wednesday,

12:15-13:30

Standard Setting and Quality Benchmarks for Medical Devices and Diagnostics in National and Global Markets

Chairs: Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India;

Ms Surina Rajan,  Director General, Bureau of Indian Standards, Government of India

Co-Chair: Mr Sudhansh Pant, Joint Secretary, Ministry of Health and Family Welfare, Government of India

Plenary Hall

Key Note Addresses:

1.      Dr VG Somani, Joint Drugs Controller India, Central Drug Standard Control Organization, India- Regulatory Landscape Reforms for Medical Devices and Diagnostics in India

2.      Dr RK Bajaj, Deputy Director General; Bureau of Indian Standards, Government of India; Dr Prakash Bachani, Head Medical Equipment Planning, Bureau of Indian Standards, Government of India- Promoting Quality through Standards in Medical Products

Panelists

1.      Dr Jitendar Sharma, CEO, Andhra MedTech Zone, and Advisor, Kalam Institute of Health Technology, India- Developing Ecosystem for Quality Diagnostics and Devices

2.      Dr Reba Chhabra, Deputy Director-Quality Control Diagnostics & HOO, National Institute of Biologicals, India- Critical Support by Labs for Quality Diagnostics

10 October 2018- Wednesday, 12:15-13:30: Parallel Session 6: Medical Diagnostics- Promoting Health For All

Time

Parallel Session 6- Wednesday, 10 October, 2018

Room

Wednesday, 12:15-13:30

Medical Diagnostics- Promoting Health For All

Chair: Dr Balram Bhargava, Secretary, Department of Health Research,  Ministry of Science and Technology, and Director General, Indian Council for Medical Research, Government of India

Co-chair: Mr Manoj Jhalani, Additional Secretary, Ministry of Health and Family Welfare, Government of India

Lecture Hall 1

Panelists

1.      Dr Ravi Kant Sharma, Deputy Drugs Controller, Central Drug Standard Control Organization, India- Regulatory Updates for Medical Devices and Diagnostics in India

2.      Dr Madhur Gupta, Technical Officer-Pharmaceuticals, WHO India- WHO India Support for National Initiative on Diagnostics and Essential Diagnostics List

3.      Dr Kamini Walia, Scientist E, Indian Council of Medical Research, India- Development of First Ever National Diagnostics List: The Indian experience

4.      Dr Zachary Katz, Chief Access Officer, FIND-Introduction of New Point Of Care Diagnostics for HIV, Malaria and TB

5.      Dr SB Sinha, Advisor Healthcare Technology, National Health Systems Resource Centre, India- Free Diagnostics (and Biomedical Equipment Maintenance) for Universal Health Coverage in India

10 October 2018- Wednesday, 13:30-14:30: Lunch

10 October 2018- Wednesday, 14:30-16:00: Parallel Session 7: Promoting Health and Wellness through Traditional Medicine

Time

Parallel Session 7- Wednesday, 10 October 2018

Room

Wednesday, 14:30-16:00

Promoting Health and Wellness Through Traditional Medicine

Chair: Mr Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH, Government of India

Co-chair: Mr Sudhir Kumar, Joint Secretary, Ministry of Health and Family Welfare, Government of India

Lecture Hall 1

Panelists

1.       Dr DC Katoch, Adviser, Ministry of AYUSH, Government of India- Integrating Traditional Medicine With Modern System Of Medicine For Achieving Public Health Goals

2.       Dr Ishwar  V Basavaraddi, Director, Morarji Desai National Institute of Yoga, Ministry of AYUSH, Government of India- The Role Of Traditional Medicine Practice In Prevention Of Non-Communicable Diseases

3.       Dr Vijay Laxmi Asthana, Senior Scientist, CSIR-National Institute of Science Communication and Information Resources, India-Traditional Knowledge Digital Library (TKDL)

4.       Dr KS Dhiman, Director General, Central Council For Research In Ayurvedic Sciences, Ministry of AYUSH, Government of India- Strengthening The Evidence Base Of Medical Products Through Research In Ayurvedic Medicine Systems

5.       Dr Asim Ali Khan, Director General,  Central Council for Research in Unani Medicine, Ministry of AYUSH, Government of India- Integration Of Traditional Medicines Into The Health Systems: The Unani Council Experience

6.       Dr Kim Sungchol, Regional Adviser- Traditional Medicine, WHO South-East Asia Regional Office, India- WHO South East Asia Regional Perspective on Traditional Medicine

7.       Dr Jing Xu, Deputy Director, National Administration of Traditional Chinese Medicine, China- Ensuring Quality and Standards In Traditional Medicines In China

10 October 2018- Wednesday, 14:30-16:00: Parallel Session 8: Developing Efficiencies in Clinical Trials in Global, Regional and National Settings

Time

Parallel Session 8- Wednesday, 10 October 2018

Room

Wednesday, 14:30-16:00

Developing Efficiencies in Clinical Trials in Global, Regional and National Settings

Chair: Dr VK Paul, Member, NITI Aayog, Government of India

Co-chair: Dr BD Athani, Former Director General Health Services; Principal Consultant, Ministry of Health and Family Welfare, Government of India

Moderater: Dr Eswara Reddy, Drugs Controller General Of India, Central Drug Standard Control Organization (CDSCO), India

Plenary Hall

Key Note Addresses-Best Practices in Clinical Trials

·         Dr Balram Bhargava, Secretary, Department of Health Research,  Ministry of Science and Technology, and Director General, Indian Council for Medical Research, Government of India

·         Dr Preetha Rajaraman, India Health Attaché, US Department of Health, US Embassy

Panelists

1.       Dr P Paul Kumaran, Scientist E, National Institute for Research in Tuberculosis, India- Ethical and Regulatory considerations in Clinical Trials in India

2.       Lt Gen Velu Nair, Group Technical Head, Cluster of Comprehensive Blood and Cancer Centres, USA & Former DG-Medical Services (Army), India- Accreditation of Ethics Committees in the Context of Clinical Trials: The India Experience

3.       Dr M Vishnu Vardhana Rao, Scientist G & Director, NIMS, Indian Council for Medical Research, India- Disclosure of Clinical Trials Results by Stakeholders: Clinical Trial Registry of India Experience

4.       Dr Sunder Raman, Head-Global Regulatory Affairs, Biocon, India- Strategies to Accelerate Access to High Quality Biosimilars for Global Patients

10 October 2018- Wednesday, 14:30-16:00: Parallel Session 9: Access and Affordability of Medical Products-Focus Orphan and Rare Drugs

Time

Parallel Session 9- Wednesday, 10 October 2018

Room

Wednesday, 14:30-16:00

Access and Affordability of Medical Products-focus Orphan and Rare drugs

Chairs: Mr Sudhanshu Pandey, Additional Secretary- Trade Policy Division, Ministry of Commerce and Industry, Government of India;

Dr Mariângela Batista Galvão Simão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals, WHO, Switzerland

Co-chairs: Mr Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India;

Dr Chandershekhar, Additional Director General, Indian Council for Medical Research, India

Lecture Hall 2

Panelists

1.       Dr S Leigh Verbois, Assistant Commissioner for International Programs, US FDA, USA- FDA Role in Facilitating Access of Medical Products for Orphan and Rare Diseases

2.       Dr Yannis Natsis, Policy Manager, Universal Access and Affordable Medicines, European Public Health Alliance, Belgium- European Public Health Alliance Contribution for Universal Access and Affordable Medicines

3.       Dr Calvin Ho, Assistant Professor, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore- Timely Access to Innovative Drugs but with Affordable Prices

4.       Dr Inthira Yamabhai, IHPP, Ministry of Public Health, Thailand- Pricing Policy and Local Manufacturing for Affordable Medicines

5.       Mr James Love, Director, Knowledge Ecology International, USA- Orphan Drugs Tax Credits and Cost of Clinical Trials

6.       Dr Anuj Sharma, National Professional Officer-AMR & Labs, WHO India- Development of Indian Priority Pathogen List (IPPL) of Antibiotic-Resistant Bacteria to Guide Research, Discovery and Development of New Antibiotics

10 October 2018- Wednesday, 16:00-16:30: Tea Break

10 October 2018- Wednesday, 16:30-17:30: Wrap Up Plenary Session: Summary of the Plenary and Parallel Sessions 

Time

Wrap Up Plenary Session: Summary of the Plenary and Parallel Sessions-Wednesday, 10 October 2018

Room

Wednesday, 16:30-17:30

Chair: Dr Balram Bhargava, Secretary, Department of Health Research,  Ministry of Science and Technology, and Director General, Indian Council for Medical Research, Government of India;

Dr RK Vats, Additional Secretary, Ministry of Health and Family Welfare, Government of India

Co-chair: Mr Sudhir Kumar, Joint Secretary, Ministry of Health and Family Welfare, Government of India

Plenary Hall

Plenary Session 3: Strengthening Regulatory Networks for Facilitating Access to Quality, Safe and Affordable Medical Products

Presentation by Rapporteur

Plenary Session 4: Global Models for High-end Manufacturing of Medical Products

Presentation by Rapporteur

Parallel Session 5: Standard Setting and Quality Benchmarks for Medical Devices and Diagnostics in National and Global Markets

Presentation by Rapporteur

Parallel Session 6: Medical Diagnostics- Promoting Health For All

Presentation by Rapporteur

Parallel Session 7: Promoting Health and Wellness through Traditional Medicine

Presentation by Rapporteur

Parallel Sessions 8: Developing Efficiencies in Clinical Trials in Global, Regional and National Settings

Presentation by Rapporteur

Parallel Sessions 9: Access and Affordability of Medical Products–focus Orphan and Rare drugs

Presentation by Rapporteur