Agenda

 

PharmaLytica 2018 Expo & Conference Inauguration Ceremony

Conference Focal Theme :

Quality Culture, Regulations & Pricing:

Healthy Components for Indian Pharma”

 

Time

Expo & Conference Opening Ceremony Agenda

10.00 am to 11.00 am

Announcement to take seats

 

Welcoming all Dignitaries, Partners and Industry Media at the Gathering

Inauguration by Lamp Lighting Ceremony

Inviting Dignitaries on Dias by Host

 

Playing of National Anthem

Screening of UBM “See You There”

Screening of UBM India Corporate AV

Screening of PharmaLytica Video

Welcome of Dignitaries on Dias by offering bouquets

Opening speech by Mr Yogesh Mudras, Managing Director, UBM India Pvt Ltd

Inaugural Address Chief Guest and invited Dignitaries on Dias

Vote of Thanks by UBM India

11.00 am to 11.15 am

Tea Break

Conference Day 1: Agenda

Theme : “Quality Culture - Revolutionizing Dynamics of Quality Assurance”

Friday, 10th August 2018

Session I: 11.15 am to 1.00 pm

A Smart Pharma Manufacturing for Operational Excellence; Latest in Pharmaceutical, Analytical & Lab”

Chair & Speaker :

Chair : Dr P V Appaji, Former DG, Pharmexcil

Presentation on “Quality Culture Demands Perfect Machine Set- up”

 

Session

Discussion on

What kind of manufacturing set up is required in pharmaceutical production facility to ensure quality product. What kind of machinery, equipment and other inputs are needed for quality production. How Human Resource is also an essential part of quality assurance and how to deal the HR aspect for quality assurance.

Speakers :

 

Mr Vijay Kriplani, President, Flow Chemistry Society

Topic : "Innovative Process Intensification for Continuous API Manufacture -- from Concept to Industrial scale"

 

Dr Vishwas Sovani, Founder Director, Pharmawisdom

Topic : “Healthy inputs for healthy products – Medical view”

 

 

Mr. M Radhakrishnan, Head-HR, Apex Lab, Chennai

Topic : “Quality Management Vs Quality Culture- Role of HR & More”

 

 

Q&A followed by Concluding remarks by Chair

 

1.00 pm to 1.45 pm

Lunch Break

Session II : 1.45 pm to 3.15 pm

Technology Edge”

 

Chair & Speaker :

Mr. Rajesh Rathi

International Society for Automation; Control infotech, USA

Presentation on “How Technology Provide the Edge for Quality Assurance”

Session

Discussion on

Information technology has already revolutionized every sector and world of work. Automation of all the manual work in pharmaceutical sector, known as pharmacy informatics, is based on the principals of IT systems. There are softwares that aid the smooth functioning of pharma units, improve their efficiency & accuracy and as a result help in improved decision making. Among many other functions pharma companies need informatics for crossing the quality chasm and preventing errors. IT, like in any other field, can also give a boost to quality assurance in pharma.

 

Speakers :

 

Dr Devraj Rambhau, Director - Technical, Pulse Pharma

Topic: “Future Perspective of Quality Culture through Technology”

 

 

Mr Subbarao V Kattamuri, Head, Aztec India

Topic: “Data Integrity for Quality Culture”

 

 

 

Q&A followed by Concluding remarks

Session III : 3.15 pm to 4.30 pm

Cost-Quality Efficiency”

Chair & Speaker :

Mr. Satish Rajkondawar, Technology Consultant, Pharma

 

Presentation on Effectively managing HR to control cost, but assuring Quality”

Session

Discussion on

Any improvement in the machines, equipment and manufacturing processes and introduction of new parameters and bench marks done for quality improvement & assurance involves cost. But not doing it also involves cost, sometimes even more than required for improvements. Not realizing this many a times cost is cited as a reason for not been able to take up the improvements in the systems. But is cost really a hindrance in quality assurance?

 

Speakers :

 

Dr. Nagarjuna Akula, Vice President Quality, Shanta Biotech

Topic: Balancing between cost and Quality”

 

 

Ganesh Balakrishnan, Partner, Deloitte Hanskins & Sells, LLP

Topic: “Is cost a barrier in Quality Culture?

 

 

Q&A followed by Concluding remarks

 

4.30 pm to 4.45 pm

Tea Break

Session III : 4.45 pm to 6.00 pm

Setting Quality Culture Parameters”

 

Chair & Speaker :

Dr R B Smarta,

Managing Director, Interlink Marketing Consultancy

Presentation on “Quality Culture Parameters – Concept & Practice”

Session

Discussion on

One major lacuna in implementing & popularising the quality culture in Indian Pharma is the lack of mechanism to measure the quality culture outcome. No parameters are yet set for quality culture outcome. Hence, quality culture articulation & development is a new industry challenge. It is of paramount importance to set such parameters for only then the quality culture will become of the manufacturing processes in all pharma manufacturing facilities. The issue of having the calibration of equipment right & precise is also important since any error in initial reading will lead to totally wrong results and diagnosis. Hence, how to know that one has perfect equipment to measure rightly calibrated is also very crucial

Speakers :

Nilesh Dhamorikar, MD, QBD Research & Development Lab

Topic: Change in  Regulatory expectations in audit

 

 

Mr. Prajwal Bhat, Achila Laboratories

Topic: “Benchmarking parameters for quality culture”

 

   Mr. Sandeep Wadakattu, DGM Life Sciences, Domino Printech
Topic : “Improving Machine readable code Quality as a part of Reliable Track and Trace           Solution”

 

Q&A followed by Concluding remarks

Closing Remarks by UBM

 

Conference Day 2: Agenda

Theme : Regulatory & Pricing – A Challenge for Pharma Sector”

 

Saturday, 11th August 2018,

 

Special Address : 11.00 am to 11.30 am

Speaker :

Mr Yognandan Pandya, Associate Director, Strategic Marketing & External Affairs, USP India

Indian pharma – Need for and current focus on Skill building and Quality Culture”

 

 

 

KeyNote Address: 11.30 am to 12.15 pm

Speaker :

Dr Eswara Reddy – DCGI

Q&A

 

Special Address: 12.15 pm to 12.45 pm

Speaker:

Dr Shubhro K Ghosh, Group Leader, Patient Access Service, Novartis Healthcare

Topic : Balancing Pharmaeconomics

 

Lunch 12.45 pm to 1.30 pm

Session I : 1.30 pm to 2.45 pm

Is Regulatory Compliance much more than GMP?”

Chair :

Ganadhish Kamat, Executive VO & Head, Global Quality organisation, Dr Reddy’s Laboratory

Presentation on “What regulators look for?”

Session

Discussion on

Quality culture, regulatory compliance, good manufacturing Practices (GMPs) and cost & pricing of products are all interwoven factors, one affecting the other in some way or the other. Thus this needs to be discussed as the subsequent part of Quality Culture. Among them there needs to bring in clarity over GMPs and mere regulatory compliance.

 

Speakers :

 

Shri Nilesh Gandhi, Assistant Commissioner, FDA, Govt of Maharashtra

Topic:  "Regulatory Mechanism for Ensuring Quality"

 

Dr Linga Rao, President – Technical Affairs, Natco

Topic: “Does GMPs make companies complacent?”

 

Q&A followed by Concluding remarks

Panel Discussion : 2.45 pm to 3.45 pm

Regulatory, Pricing & Patients – Eqlibrium”

Moderator:

Utkarsh Palnitkar, Partner, KPMG/Dr R B Smarta

Invited Dignitaries:

 

 

Sri T.Kailasam, Joint Director, Drugs Control Administration, Telangana


 

 

Sri M.B.R. Prasad, Director, Drugs Control Administration, Andhra Pradesh

 

 

Ms Binita Kundu, AR Strategist, Global Regulatory Affairs, Pfizer Healthcare India

 

Q&A followed by Concluding remarks

3.45 pm to 4.00 pm

Vote of Thanks & Closing Ceremony

 

 

Supporting Associations
Conference Partners

Media Partners