SELECTBIO - QbD in Pharma Development World Congress 2017 Agenda

Thursday, 20 April 2017

Agenda

08:00

Registration

10:00

Inauguration

10:10

Welcome Address by MD SELECTBIO

10:15

P B N Prasad

Guest of Honour

Inaugural Address
P B N Prasad, Deputy Drugs Controller (India), Central Drugs Standard Control Organization, India

10:45

Coffee Break

Session 1: QbD for Holistic Pharma Development

11:15

Bhupinder Singh Bhoop

Keynote Presentation

QbD for Holistic Pharma Development: Excellence Precedes Compliance
Bhupinder Singh Bhoop, Dean, UIPS, Panjab University, India

12:05

A Holistic Approach of QbD in Pharmaceutical Industry
Korupoju Srinivasa Rao, Director-QbD PharmaSolutions, Piramal Enterprises Limited, India

12:50

Poster Viewing

13:00

Lunch Break

Session 2: QbD in API Development and Manufacturing

14:00

QbD in API Manufacturing Process: Strategy for Successful timely Regulatory Approval using QbD
Sushil Srivastava, Process Research and Development Director, Bristol-Myers Squibb, United States of America

14:40

QbD in API Development: A Luxury or Necessity?
Dhileep Krishnamurthy, CSO, Zhejiang NHU Company Ltd, China

15:20

Coffee Break

Session 3: QbD in Analytical Development

15:40

Quality by Design – Application to Analytical Method Development
Mrunal Jaywant, Senior Director, USP India Private Limited, India

16:20

Quality by Design in Analytical Method Development
Gautam Samanta, Vice President - Quality by Design and Process Scale-up, Cipla Ltd, India

17:00

Panel Discussion : QbD Implementation: Current Status and Regulatory Perspective

17:40

End of First Day of Conference

Friday, 21 April 2017

09:30	“QbD Driven Technology Transfer: An Overview of Some of the Elements, Nuances and Challenges in the Industry” Shib Mookherjea, Senior Director, ValQual International, United States of America
10:30	Coffee Break
	Session 4: Enhanced Product and Process Understanding for QbD

11:00	PAT for Pharmaceutical Applications: Enhanced Product and Process Comprehension in Manufacturing Sciences Suresh Kumar, Team Lead, Novartis, India
11:40	Application of Multivariate Tools and Artificial Neural Networking in Science Based Development of Novel Drug Products in PAT and QbD Era Asha Patel, Associate Professor, Parul University, India
	Session 5: DoE as the Pivot in QbD Implementation

12:20	Successful DOE/QBD in Generic Pharma Industries Quaisar Anwar, Assistant Vice President, Recipharm Pharmaservices Pvt. Ltd, India
13:00	'Understanding DOE - Strategies for Success and Pitfalls to Avoid Nalini Shastri, Associate Professor, National Institute of Pharmaceutical Education and Research, India
13:40	Lunch Break
	Session 6: QbD in Developing Formulations and Biologics

14:40	Quality by Design (QbD) for Formulation Development Devendra Ridhurkar, Senior Scientist, Egis Pharmaceuticals, Hungary
15:20	Application of QbD Principles in Biologics Drug Product Development Satish Singh, Head, Lonza Inc, Switzerland
16:00	QbD in BA/BE Neerja Somyajee, Manager, Anacipher Clinical Research, India
16:40	Poster Presentation Award
16:45	Closing Remarks and Vote of Thanks
17:00	End of Conference