6th Regulatory Conference

Overview

New Conference dates - May 23-24, 2013

This conference brings prominent industry experts, senior management professionals, academicians and regulators together to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharmaceutical industry. While the achievements in reaching global standards in India have been significant, a lot more needs to be done to stay competitive in the world market due to ever-evolving stringency on regulatory enforcements. This conference brings together the best talent in the pharmaceutical world to understand what the challenges are, deliberate how to be prepared to face up to these complexities by learning from the past, and decide proactive measures that could be taken by the industry.

Who Should Attend

Professionals with experience in clinical safety and who are involved in:

Regulatory Affairs from Government and Industry
Clinical Research and Development
Safety and Pharmacovigilance
Clinical Trial and Project Management
CMC/Quality (Quality, Manufacturing and Controls)
QA and QC
Product Development

Learning Objectives

All attendees will receive a DIA certificate of Attendance at the conclusion of the event.

This two-day conference offers a unique opportunity for key stakeholders from health authorities, local and multinational pharmaceutical companies, and clinical research to meet and exchange views, discuss topics of interest, and identify focus areas for ongoing efforts to increase patient access to new and improved medicines. This conference will provide a forum to facilitate discussion on common issues in the regulatory and technical areas in India.

Hotel & Travel

Attendees should make airline reservations as early as possible to ensure availability. Courtyard Ahmedabad (Marriott) is holding a block of rooms at the reduced rate below until March 25, 2013 for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

Single INR 6500 INR (CP Plan without taxes), Breakfast and Airport transfer included)

Courtyard Ahmedabad (Marriott) – Ramdev Nagar Cross Road, Satellite Road, Ahmedabad, 380015 India
Contact Person: Leena Bhindora, Assistant Sales Manager
Cell: +91.90.9901.7743; Tel: +91.79.6618.5098; Fax: +91.79.6618.5299;
email: Leena.Bhindora@courtyard.com

Contact Information

Meeting Manager:

Manoj Trivedi, Senior Manager Marketing and Program Development, DIA India
Cell: +91-98-1977-7493
Phone: +91-22-6765-3226
Email: Manoj.Trivedi@diaindia.org

Program Committee

Previous Next

Program Committee 1-3 of 13

Hemant Koshia

Commissioner
Food and Drugs Control Administration, Gujarat, India

K. Anand

President, Global Quality and Regulatory Affairs
Zydus Cadila, India

Rajeev Mathur

Head, Global Regulatory Affairs
Ranbaxy Laboratories Limited, India

Program Committee 4-6 of 13

Y.D. Chauhan

Joint Commissioner
FDCA, Gujarat, India

Sukanya Chaudhary

Senior Manager, Regulatory Affairs
GSK, India

Albinus M. D'Sa

Deputy Country Director
US FDA, India

Program Committee 7-9 of 13

R. L. Vaishya

Joint Commissioner
FDCA, Gujarat, India

Zoher Sihorwala

VP Global Regulatory Affairs
Dr. Reddy's Lab, India

A. Ramkishan

Asstistant Drug Controller
CDSCO, Gujarat, India

Program Committee 10-12 of 13

Shrenik Shah

Director
Montage Laboratories (Pvt.) Ltd., India

Vinay Nayak

President Technical
Alembic Pharmaceuticals, India

Rajkiran Jain

Vice President - IRA
Zydus Cadila, India

Program Committee 13-13 of 13

Dushyant Patel

Chairman & Managing Director
Astral SteRitech Private Limited, India

Agenda

Day 1 Thursday, May 23, 2013

9:15AM - 9:30AM
Introduction
9:30AM - 10:00AM
Guest of Honor
Speaker(s):
- G. N. Singh
  Drug Controller General of India (DCGI)
  India
10:00AM - 10:30AM
Keynote Speaker
Speaker(s):
- Rajiv Gulati
  President, Global Pharmacueticals Business
  Ranbaxy Laboratories Limited, United States
11:00AM - 12:00PM
Session 1: Dosage Forms
Speaker(s):
- GbD Approaches in Drug Development
  Subramanian Iyer
  Associate Vice President
  Mylan Laboratories Limited, India
- Regulatory in Aseptic Technologies
  M. S. Mahadevan
  President & Chief Executive Officer
  Biozeen, Millipore, India
12:00PM - 1:00PM
Session 2: Biologicals
Speaker(s):
- Regulatory Pathway in Biosimilars
  Sanjeev Kumar
  Senior Vice President
  Zydus Cadila, India
- Role of Biological Assessment in Drug Discovery
  Ivy Louis
  Founder
  Vienni Training & Consulting LLP, India
2:00PM - 3:00PM
Session 3: Medical Devices
Speaker(s):
- Regulatory Aspects of Devices & Drug Combination Products
  Daniel Shoukier
  Global Regulatory Affairs Director
  Biosensors International, Germany
- Regulatory Paradigm for Medical Devices Clinical Trials in India
  Sumati Randeo
  Associate Director, Regulatory Strategy & Policy Advocacy, Asia Pacific
  Abbott Labs, India
3:30PM - 5:00PM
Session 4: Skill Development
Speaker(s):
- Role of Training of Enhancement of Human Skills
  Ivy Louis
  Founder
  Vienni Training & Consulting LLP, India
- Interface of Academia in Shaping Young Students to Future Industry Challenges
  Yusuf Jaliwala
  Principal
  Indore Institute of Pharmacy, India
- Business Development in Pharma Industry: Opportunities and Challenges
  Alok Sonig
  India Head, Senior Vice President, Global Generics
  Dr. Reddy's Lab, India

Day 2 Friday, May 24, 2013

9:15AM - 10:45AM
Session 5: Regulatory Challenges in Emerging Market
Speaker(s):
- Regulatory Challenges In Emerging Market - Special Emphasis on BRICS
  Hasumati Rahalkar
  Founder
  Metina Consultants, India
- Regulatory Challenges In Emerging Market - Special Emphasis on BRICS
  Rajeev Mathur
  Head, Global Regulatory Affairs
  Ranbaxy Laboratories Limited, India
- Life Cycle Management of Pharmaceuticals in Regulated Market
  Zoher Sihorwala
  VP Global Regulatory Affairs
  Dr. Reddy's Lab, India
11:00AM - 12:30PM
Session 6: APIs
Speaker(s):
- ICH Q11-Challenges in Implementation
  Rajiv Desai
  President, Quality
  Dishman Pharmaceuticals and Chemicals Ltd., India
- Setting Quality Standards in Drug Substances
  Surendra Nath
  Partner
  S. Nath & Co., India
1:15PM - 2:45PM
Session 7: Regulatory Affairs
Speaker(s):
- Challenges in Quality/Regulatory System in Indian Perspective
  A. Ramkishan
  Asstistant Drug Controller
  CDSCO, Gujarat, India
- Laboratories Expectations in Regulatory Market Environment
  K. Anand
  President, Global Quality and Regulatory Affairs
  Zydus Cadila, India
3:00PM - 4:30PM
Session 8: Regulatory Affairs - IT Perspective
Speaker(s):
- Regulatory Intelligence
  Siddharth Shah
  Associate Director, LS R&D Practice
  Cognizant, India
- Regulatory Affairs Leveraging Cloud Computing
  Vikram Anand
  Associate Vice President, Cloud and Commercial Operations
  Aris Global, India
4:30PM - 5:15PM
Panel Discussion/Fire Chat
Speaker(s):
- Hemant Koshia
  Commissioner
  Food and Drugs Control Administration, Gujarat, India
- A. Ramkishan
  Asstistant Drug Controller
  CDSCO, Gujarat, India
- Zoher Sihorwala
  VP Global Regulatory Affairs
  Dr. Reddy's Lab, India
- K. Anand
  President, Global Quality and Regulatory Affairs
  Zydus Cadila, India

Exhibits

The 6th Regulatory Conference offers interested companies the opportunity to exhibit with a tabletop display as well as alternative support and marketing opportunities.

Tabletop - INR 50,000
Includes:

One (1) complimentary full-meeting registration
One (1) exhibit personnel registration
One (1) table
Two (2) chairs

Banner - INR 15,000

Additional Opportunities
Please see the PDF below for additional information about the following:

Conference Supporter (Includes Tabletop) - INR 300,000
Speaker Dinner Partner - INR 250,000
Lunch Partner - INR 250,000
Delegate Kit Partner - INR 200,000

Any staff required above those allotted per purchased product must register as a full attendee incurring full registration fees. Additional expenses associated with the exhibit, including special booths, drayage, lights, phone, carpeting, electrical connections, etc., will be the responsibility of the exhibitor.

Useful Links:

Application and Contract for Tabletop and Support/Partner Opportunities
Support & Partner Opportunities
Final Program Advertising

Thank you to our Media Partners

Exhibiting Companies 1-9 of 9

Caliber Technologies Pvt. Ltd.
Educe Solutions Pvt Ltd.
LORENZ Life Sciences India Pvt. Ltd.
Minitab
PDP Life Science Logistics India Pvt. Ltd.
Sarjen Systems Pvt. Ltd.
SOTAX India (Pvt) Limited
TAKE Solutions
Thermolab Scientific Equipments Pvt. Ltd.

Registration Fees

Other Fees

Charitable Nonprofit/Academia: Rs4000.00

Member

Member Standard: Rs8500.00

Non-Member

NonMember Standard: Rs9000.00

Group Discounts

Register 10 from your company and receive the 11th FREE! Contact our group discount representative for details or call +91.98.2058.7798

CANCELLATION POLICY: On or before MAY 15, 2013

Cancellations must be in writing and received by MAY 15, 2013. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. If the event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. DIA reserves the right to alter the venue, if necessary.

Upon cancellation, the administrative fee that will be withheld from refund amount is:

Member/Nonmember Registration = INR 3,000
Student Registration = INR 500

All refunds will be issued in the currency of original payment

Register Online

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