Conference On ‘Global Regulatory Considerations for Pharma and Biotech Products’

07th November, 2014
Hotel Jaypee Siddharth, New Delhi
Time: 9:00 am to 6:00 pm

Organized By:
Auriga Research Ltd.
(www.aurigaresearch.com)
&
Canton Pharma Consultants
(www.cantonpharmaconsultants.com)

Purpose of the Conference:

Regulatory Affairs is a dynamic scenario where the requirements and expectations keep evolving every day. Auriga Research Limited and Canton Pharma Consultants jointly invite you to the regulatory conference being held on 7th Nov 2014.The conference shall take you to the tour of global regulatory considerations for Pharma and Biotech products. It will be a live session to upgrade your knowledge and expertise in consultation with pioneers of the field.

The conference shall benefit a wide span of audience belonging to the field of Regulatory Affairs, Formulation Development, Analytical & Quality Control staff, Biotechnology Groups, Global Material Supply Personnel, Project Managers and Quality Assurance Departments.

All speakers are Pioneers of their respective field and have been associated with major Pharma companies involved in global filings. Their expertise and knowledge is matchless and invaluable.
If you are looking to enhance your knowledge, clear your doubts and improve your skills for regulatory submissions supported by product development, analytical methodology and allied fields, this is the comprehensive programme designed for you.

Briefly,

Auriga Research Ltd. is complete solution CRO for the development, marketing authorization and registration of quality pharmaceutical, herbal, cosmetics, biological, medical devices and biotechnology products in India and rest of the world. We support numerous clients for registration of New Drugs covering Regulatory Consulting, Bio-Equivalence Studies, Clinical Trials, Formulation Development, Stability Studies, Analytical Development and GCP, GMP, GLP audits.

Canton Pharma Consultants is a group of experienced professionals from Pharmaceutical domain and provide a full range of regulatory affairs solutions. Canton is dedicated to deliver the highest quality support, helping your company to gain approval for your medicine pipeline in a timely and cost-effective manner. We focus on achieving full commercial potential for all products. Our regulatory team has the skills and proven ability to advise and manage a variety of regulatory projects of all sizes.

 Agenda & Faculty:

Agenda & Faculty:

8:15 am – 09:00 am	Registration, Welcome Tea / Coffee
	Topic	Faculty
09:00 am – 09:15 am	Welcome and Inauguration	Dr. Khalid Khan, Director- Fermish Clinical Technologies Pvt. Ltd.
09:15 am – 10:00 am	Keynote Address- Quality Approach of Pharma Industry for 21st Century	Dr. D. Roy, Former Deputy Drugs Controller (India) CDSCO, Min. of Health & FW, Govt. of India
10:00am – 10:45 am	Recent Regulatory Updates (US/EU/Australia/C7anada)	Dr. Prafulla Nandi (Associate Vice President, Jubilant Life Sciences Limited)
10:45 am – 11:00 am	Tea Break
11:00 am – 11:45 am	QBD in Formulation Development	Dr. Romi Singh Associate Director , Ranbaxy Labs Ltd
11:45 am – 12:30 pm	Regulatory challenges in emerging market (Africa/CIS/APAC)	Ms. Mamoona Firdous Naqvi (Manager Regulatory Affairs, Gulf Pharmaceutical (UAE)
12.30 pm – 13.15 pm	Regulatory Compliance	Ms. Renu Bala  (Sr. General Manager – Regulatory Affairs, Nectar Lifesciences Ltd)
13:15 pm – 14:00 pm	Lunch Break
14:00 pm – 14:45 pm	Effective dossier writing	Mr. Manu Babbar (Founder Canton Pharma Consultants)
14:45 pm – 15:30pm	Regulatory requirements for WHO pre-qualification of Vaccines	Ms. Archana Kheiterpa (Dy.General Manager Regulatory, Panacea Biotec)
15:30 pm – 16:00 pm	Tea Break
16:00 pm – 16:45 pm	Regulatory requirement for export of Pharmaceuticals and Biologicals in India	Mr. Kuldeep Wakhloo (Chief of Regulatory affairs, Lupin Ltd.)
16:45 pm – 17:30 pm	Global regulatory scenario on OTC products	Mr. Anoop Kumar Mishra (Manager Regulatory Affairs, Reckitt Benckiser India
17.30 pm- 18.00 pm	Analytical aspect of regulatory dossier filing	Dr Saurabh Arora (Managing Director, Auriga Research Ltd.)
18:00 pm	Conclusion

Regulatory Affairs Managers/Officers/ AssistantsStakeholders who should attend the Conference:

• Compliance Managers
• Documentation Managers
• Product Registration Personnel
• Project Managers in Regulatory Affairs
• Quality Assurance personnel
• Key contributors to the submission package
• Global business development

Registration Fees:

	Early Bird Discount (Register till 15th October 2014)	Registrations after 15th October 2014
Delegate fees*	4000/-	5000/-

Payment Mode:

• Cheque (In favour of ‘Canton Pharma OPC Private Limited’), to be couriered to: Auriga Research Limited, 3/15, Kirti Nagar Industrial Area New Delhi-110015
• Direct transfer / Online Transfer to account, details:

A/c holder’s Name: Canton Pharma OPC Private Limited
A/c No: 606420110000189
Bank Name: Bank of India, Bank Branch: Pitampura, Delhi
IFSC Code: BKID0006064

Our Past Achievements:

Auriga Research Ltd. has successfully conducted below mentioned events focusing on recent regulatory challenges in conduct of clinical trials in India.

• Conference on “Recent changes in the regulatory scenario of India, with respect to Serious Adverse Events, Compensation and Registration of Ethics Committees” on 10th April, 2013 with SenseCR, in collaboration with Jamia Hamdard University, New Delhi.
• Conference on “Preparing Sites for Quality Clinical Trials – The Need of the Hour” on 31st August, 2013 with SenseCR, in collaboration with Tata Memorial Hospital, Mumbai.
• Conference on “Adapting to the Current Regulatory Challenges in conduct of Clinical Research – Focus on Sites and Ethics Committees” on 09th Nov 2013 with SenseCR, in collaboration with Rajiv Gandhi Cancer Institute at in India Habitat Centre, New Delhi.
• Workshop on “Latest Regulatory Environment – Empowering Sites & Ethics Committees, The Legend Inn, New Delhi, on 10th May 2014 with SenseCR and Cytespace.
• Hands-On Workshop on “Latest Regulatory Environment – Empowering Sites & Ethics Committees” on 12th July 2014, in Royal Orchid Central, Dickenson Road, Manipal Center, Bangalore with SenseCR and Cytespace.

Canton Pharma Consultants has successfully conducted below mentioned events focusing on CTD Dossier Writing.

• Regulatory Workshop on CTD Dossier writing in conjunction with Indian Pharmaceutical Association at faculty of Pharmacy, Jamia Hamdard.
• Regulatory Workshop on CTD Dossier writing in conjunction with Ennoble IP at IEC college, Greater Noida.

Partnership/ Sponsorship Opportunities:

Grab this opportunity to network with regulatory professionals and showcase your services and products.
For sponsorship enquiries, please write to us [email protected], or call to Mr. Nishant Singh at: +91 9540930950
Contact details for further assistance:
Dr. Manoj Karwa, Head – Clinical Operations, Auriga Research Limited
Mr. Manu Babbar, Canton Pharma Consultants, Delhi
PH No.: +91-9818561555, +91-11-45042691, +91-11-45754540
Email id: [email protected], [email protected]