DAY 1 – FRIDAY, OCTOBER 9, 2015Schedule Topics Speakers 9.00am–10.00am REGISTRATIONS – Tea / Coffee

10.00am–12.00pm INAUGURAL SESSION Facilitator – Mr. Daara B. Patel, Secretary-General IDMA

10.05am–10.15am Welcome Address Mr. Daara B. Patel, Secretary-General, IDMA

10.15am–10.25am Significance of PAC- Journey through 18 Years

Mr. J.L. Sipahimalani, Chairman, Quality Management & Technical Subcommittee, IDMA & Chairman APA

10.25am–10.40am WHO Initiatives & India’s Contribution to World Health

Dr. Arun Thapa,WHO Representative in India

10.40am–10.50am Address by Mr. Jim Tizzard Chief Executive Officer, Navitas Life Sciences Limited, UK

10.50am-11.20am

Introduction of Chief Guest

&

Keynote Address by Chief Guest

Mr. Daara B. Patel, Secretary-General, IDMA

Mr. Subhanu SaxenaManaging Director & Global Chief Executive Officer, Cipla Ltd

11.20am-11.35 am Release of Souvenir, APA Forum & Presentation of Awards

11.35am–11.40am Vote of Thanks Mr. S.M. Mudda, Chairman, Regulatory Affairs Subcommittee, IDMA

Inauguration of Exhibit Area

11.40am–12.00am Tea / Coffee Break

TECHNICAL SESSION Facilitator:– Dr. Milind Joshi, President, Global Regulatory Management, J.B. Chemicals & Pharmaceuticals Ltd Assisted by:- Ms. Priya Shindurnikar, Asst. Secretary-General, IDMA

Schedule Topic Speakers 12.00pm–12.20pm Initiatives of United States Pharmacopoeia Dr. K.V. Surendranath

Sr. Vice President, International Site Operations, United States Pharmacopoeia India (P) Ltd

12.20pm -12.40pm Initiatives of Indian Pharmacopoeia Commission

Dr. P.L. Sahu, Principal Scientific Officer, Indian Pharmacopoeia Commission

12.40pm-1.00pm Integrating to the global QMS … … Best Practices

Mr. Marty Boom,Chief Operations Officer, Navitas , USA

1.00pm–2.00pm Lunch, Networking, Visit to Exhibit AreaTECHNICAL SESSION – QUALITY BY DESIGN (QbD)

2.00pm–2.45 pm QbD–Aspects in Formulations Dr. Sumedha Nadkar, Site Head & Director – Consumer Healthcare R & D, Perigo API Pvt. Ltd

2.45pm–3.30 pm QbD-Aspects in Analytical Methods ** Ms. Abha Pant,Vice President R&D, IPCA Laboratories Ltd

3.30pm–4.00pm Networking & Tea / Coffee BreakTECHNICAL SESSION – QUALITY RISK MANAGEMENT (QRM)

4.00pm-4.45pm QRM in Manufacturing Operations Dr. Uday Shetty,Chief Executive Officer, Drug Regulations (Non-Profit organization)

4.45pm-5.30pm QRM in Laboratory Operations Dr. Vivek Jadhav,Chief Executive Officer, VAB Pharma

5.30pm–6.30pm Visit to Exhibit Area 6.30 pm onwards Cocktails & Dinner

(** Subject to Change )

DAY 2 – SATURDAY, OCTOBER 10, 2015Schedule Topics Speakers 09.00am – 09.30am Morning Refreshments & Networking

TECHNICAL SESSION – QUALITY SYSTEM 09.30am–10.15am Quality System Approach for

Global Compliance Mr. Abhijit Kulkarni,General Manager, (Quality), GlaxoSmithKline Pharmaceuticals Ltd

10.15am–11.00 am Quality Matrics Mr. S.M. Mudda,Chairman, Regulatory Affairs Subcommittee, IDMA

11.00am–11.30am Networking & Tea/Coffee BreakTECHNICAL SESSION – VALIDATION

11.30am-12.15pm Process Validation **Mr. S.G. Belapure,President Operations, Zydus Cadila

12.15pm–1.00pm Analytical Method Validation **Dr. Prashant Dixit,Watson Pharmaceuticals

TECHNICAL SESSION – GOOD DISTRIBUTION PRACTICES 1.00pm – 1.30pm Good Distribution Practices Mr. Amit Masurekar,

Founder Director, AIOCD AWACS 1.30pm – 2.30 pm Lunch, Networking, Visit to Exhibit Area 2.30pm – 3.30pm BREAKOUT SESSIONS

1. Meeting Challenges/Expectations in Quality by Design Thought Leader: Ms. Meena Shah, General Manager-Regulatory Geltec Pvt. Limted

2. Meeting Challenges/Expectations in Quality Risk Management Thought Leader: Dr. Uday Shetty, Chief Executive Officer- Drug Regulations ( Non – Profit Organization)

3. Meeting Challenges/Expectations in Quality Management Thought Leader: Mr. Abhijit Kulkarni, General Manager-Quality GlaxoSmithKline Pharmaceuticals Limited

4. Meeting Challenges/Expectations in Regulatory Compliance Thought Leader : Mr. Arun Mishra, Director-Regulatory Affairs Abbott Limited

3.30pm – 4.30pm Summary / Plenary Session co-ordinated by Dr. Milind Joshi

4.30pm – 5.00pm Open House

5.00pm – 5.15pm Concluding Remarks & Vote of Thanks by Mr. Daara B. Patel, Secretary-General, IDMA

5.15pm onwards Hi - Tea

(** Subject to Change )