Programme

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Special Lectures

• Benefits of Harmonisation
  
• Role of Standards

Proposed Workshop Topics

• Device Classifications
  
• ISO 13485
  
• Conformity Assessment
  
• Post Market Surveillance
  
• Risk Management
  
• In-vitro diagnostic devices
  
• GMDN/UMDN and Clinical Evaluation
  

Distinguished Speakers

Government of India

Dr. Anbumani Ramadoss, Hon'ble Union Minister, Ministry of Health and Family Welfare (Invited)

Shri Naresh Dayal, Secretary, Ministry of Health and Family Welfare (Invited)

Dr. R. K. Srivastava, Director General Health Services, Ministry of Health and Family Welfare

Shri Debasish Panda, Joint Secretary, Ministry of Health & Family Welfare
Govt. of India

Dr. Surinder Singh, Drugs Controller General (India), Ministry of Health and Family Welfare

Shri Malay Mitra, Assistant Drugs Controller (India), Ministry of Health and Family Welfare

International

Ms. Carolyn Albertson, Senior Director-International RA, Abbott Laboratories, USA

Dr. Phillipe Auclair, Director, Regulatory Affairs, Quality Assurance and Compliance, Abbott Vascular International, Belgium

Ms Rosette Berberian, Manager- International Regulatory Affairs, Advanced Sterilization Products, Johnson and Johnson Company

Mr. Gerry Buss, Executive, Global Regulatory Affairs, GE Healthcare, USA

Dr. Michael B Gropp, Vice President, Global Regulatory Strategy
Medtronic, Inc., USA

Mr. Jack Moore --Director Regulatory Affairs Asia Pacific, Singapore

Dr. MS Pillay, AHWP Chairman

Mr. Jack Wong, Vice President Regulatory Affairs - Asia, General Manager, Hong Kong, BSI Product Services