1. The document announces the 1st Annual Conference on Total Excipient Control hosted by IPEC India on July 21, 2016 in Mumbai. 2. IPEC India is the Indian chapter of the International Pharmaceutical Excipients Council (IPEC) Federation which promotes quality standards for excipients globally. 3. The conference aims to educate pharmaceutical professionals on Total Excipient Control and how it is important for ensuring quality, safety and efficacy of drugs in India and abroad. The agenda includes presentations and panels on excipient regulations, standards, and supply chain controls.

1. 1st
ANNUAL CONFERENCE
Thursday 21st
July 2016
The Westin Mumbai Garden City, Goregaon, Mumbai
The Need
For
Total
Excipient
Control

2. About IPEC India
The IPEC Federation is a global organization that promotes quality in pharmaceutical
excipients. IPEC currently is a federation of four independent regional industry
associations headquartered in the United States (IPEC-Americas), Europe (IPEC-
Europe), Japan (JPEC), and China (IPEC-China) with India (IPEC-India) incorporated
as its associate member - provides a unified voice to promote the best use of
excipients in medicines as a means of improving patient treatment and safety. IPEC-
India was registered in the year 2014 in India and is a not-for-profit organization.
Key objectives for the Federation will be harmonization of standards, promoting
supply chain security, and the further development of third-party certification, as well
as providing a source of advice and expertise for other stakeholders on excipients.
Excipients play a critical role in the manufacture of medicines by helping to preserve
the efficacy, safety, and stability of active pharmaceutical ingredients (APIs), and
helping to ensure that they deliver their promised benefits to patients. Optimal use of
excipients provides pharmaceutical manufacturers with drug development cost-
savings, enhanced functionality capability and can also assist in drug formulation
innovation.
Why you should attend
If you work in pharmaceuticals as an excipients professional, an API professional or
a formulations professional, you will know that it is critically important to understand
excipients and the role they play in the quality of your product, and the best way to
understand this is by understanding Total Excipient Control and what it means.
At IPEC we believe that the pharma industry will be placed on a much more robust
footing if all pharma professionals felt comfortable with Total Excipient Control. That
is why we have set up this event – to ensure that people in pharma are introduced to
this concept and understand how it affects various aspects of their jobs.
Attendance at this event will give you both the knowledge and the confidence you
need when dealing with excipients, both for the domestic Indian market and for the
export-oriented generics market.

3. Agenda
Inaugural session
0900 hrs – 0915 hrs Introduction to IPEC
India
Ajit Singh, Chairman
IPEC India and ACG Worldwide
0915 hrs – 1000 hrs Presentation on “Total
Excipient Control
(TEC)”
Dave Schoneker
Global Expansion Coordinator ,IPEC Federation &
Director of Global Regulatory Affairs, Colorcon
1000 hrs – 1020 hrs Address on “ The Need
for Excipient Control in
India” by Chief Guest
Dr G N Singh, IAS
Drugs Controller General of India (DCGI)
1020 hrs – 1040 hrs Address by Guest of
Honour
Sudhanshu Pandey, IAS(*TBC)
Joint Secretary, Department of Commerce
Ministry of Commerce & Industry of India
1040 hrs – 1110 hrs Panel Discussion on
“Implementing
Excipient Rules”
 Ajit Singh
 Dave Schoneker
 Sudhanshu Pandey, IAS, Joint. Secretary.(*TBC)
Ministry of Commerce & Industry of India
 Dr G N Singh, IAS, DCGI
 Subodh Priolkar
 Peter Salazar
Networking break – 1110 hrs – 1130 hrs
Session 2 – Excipient Standards
1130 hrs – 1200 hrs Excipient GMP & GMP
Auditing/ Certification
(EXCiPACT & ANSI
/NSF/ IPEC 363)
Dave Schoneker
Global Expansion Coordinator ,IPEC Federation &
Director of Global Regulatory Affairs, Colorcon
1200 hrs – 1230 hrs Pharmacopoeial
Harmonisation &
Excipient Initiatives
Dr Sameer Navalgund
Vice President, USP–India
1230 hrs – 1300 hrs Elemental Impurities –
Implementation
Challenges
Dave Schoneker
Global Expansion Coordinator ,IPEC Federation &
Director of Global Regulatory Affairs, Colorcon
Lunch – 1300 hrs – 1400 hrs

4. Session 3 – Guidelines
1400 hrs – 1430 hrs Implementing Excipient
Standards- IPEC’s
Excipient Qualification
Guide
Peter Salazar (TBC*)
Managing Committee Member ,IPEC India &
Head Process Solutions, Merck Limited
OR
Seema Kamath (TBC*)
Chair of Communication Committee, IPEC India &
Manager- Global Regulatory Management Life Science ,
Merck Limited
1430 hrs – 1500 hrs IPEC’s Significant
Change/COA Guidelines
Vishakha Metkar
Chair of Regulatory Affairs Committee, IPEC India &
Manager of Global Regulatory Affairs, Colorcon
1500 hrs – 1530 hrs IPEC’s EXCiPACT T.S .Shadagopan
Product Manager - GMP & Senior GMP Auditor Systems and
Services Certification S&SC), SGS India Pvt Ltd
Networking Break – 1530 hrs – 1600 hrs
Session 4 – Supply Chain Controls
1600 hrs – 1630 hrs Risk Assessment and
GDPs
Kedar Chikhalikar
Managing Committee Member,IPEC India &
Associate Head – Technical Services & Application
Lifesciences Polymers, Lubrizol Advanced Materials India Pvt
Ltd
1630 hrs – 1700 hrs Implementing Supply
Chain Controls in India
*TBC
1700 hrs – 1730 hrs The Formalized Risk
Assessment for
Excipients A Practical
Approach
Mr Umakanth Kanna
Head of Regional Technical Services, Pharma Solutions.
BASF South East Asia Pte Ltd,Singapore
1730 hrs – 1800 hrs Conference Closing –
Where do we go from
here?
Subodh Priolkar
Vice Chairman, IPEC India &
Managing Director, Colorcon Asia Pvt Ltd
*TBC – To be confirmed
For further details contact:
Ms. Dipali Mahadik
Executive
E-mail : admin@ipecindia.org
International Pharmaceutical Excipients Council of India
1001, Dalamal House, 10th Floor, Nariman Point, Mumbai- 400 021 India
Tel: 91 22 3008 9463 / 2287
Fax: 91 22 2287 2560

5. Registration Form
Delegate Fees:
 Members : Rs. 10,000/-
 Non-members: Rs. 15,000/-
Cheques/Demand Drafts should be made out in favour of “International Pharmaceutical Excipients Council of India.”
NEFT ( Direct Bank Transfer) payment is also available. Please contact us for details.
Please send payment to:
International Pharmaceutical Excipients Council of India (IPEC INDIA)
1001 Dalamal House, 10th Floor
Nariman Point, Mumbai 400 021 India
Tel : 91 22 2287 2557 /3008 9463
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Date & Issuing
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1ST
ANNUAL CONFERENCE 2016
ON
THE NEED FOR TOTAL EXCIPIENT CONTROL
Thursday, 21st
July 2016
The Westin Mumbai Garden City, Goregaon, Mumbai