Binori Hotel, Ahmedabad, India

Venue :

PROGRAM CHAIR

Dr. Rajendra Jani

Scientific Expert & Management Adviser

Basilion Healthcare And Research

PROGRAM CO-CHAIR

Mr. Arvind Kukrety

Deputy Drugs Controller (India)

Ahmedabad (Zonal office), CDSCO

National Scientific Conference on

“REGIONAL & MULTI-REGIONAL CINICAL TRIAL (MRCT)

FROM GLOBAL REGULATORY PERSPECTIVE”

“International Clinical Trial Day”An event to commemorate

thOn Saturday, 11 May 2019Organized by

“Empowering India from Science, Ethics and Resources towards Innovation"

Program Committee

Keynote Speakers & Experts

Recently Ministry of Health & Family Welfare and CDSCO have notified New Drugs and Clinical Trial Rules, 2019 with the objective to create friendly environment for enriching growth of clinical research in India with due consideration of science, ethics & resources which will ultimately ensure faster & more effective treatment access to our patients. Indian Clinical Research Professionals are so much thankful to our respected regulatory for the big progressive step towards our society.

Now the time has come to nurture individual’s skill towards innovation and economy of nation to represent India across glob for clinical research, where science, ethics and resources are prime focused.

The conference objective is to have in-depth understanding of recent regulatory changes and to engage clinical research professional in discussion on innovative approaches related to science, ethics and resources in regional & multi-regional clinical trials and the clinical research landscape in India.

Mr. Darshan DaveM.Pharma. (Pharmacology)

Founder & Managing DirectorBasilion Healthcare And Research

Organizing Host

Dr. Mira DesaiM.D. (Pharmacology)

Clinical Pharmacologist

Dr. Mita Nandy M.D. (Pharmacology)

Consultant, New Drugs, CDSCO-INDIA

Dr. Rajendra JaniPhD (Medical)

Scientific Expert & Management AdviserBasilion Healthcare And Research

Program Chair

Dr. Sanish DevisD.M. (Clinical Pharmacology)

Senior Medical Director, CVMER Head, GCTO, Covance, India

Dr. Bhaswat ChakrabortyPhD (Clinical Pharmacology)

Professor Emeritus at Institute of PharmacyNirma University

Dr. Charu Gautam MD, DNB, Senior Medical Director and

Head Phase I, Asia Pacific, IQVIA

Dr. Chirag DesaiMD, DM (Oncology)

Vedant Hospital

Mr. Kapil JhawarMS Pharm (Clinical Pharmacy)

Associate Director-Project ManagementAsia Pacific, IQVIA

Dr. Vinu Jose M.D., D.M. (Clinical Pharmacology)

Associate Vice PresidentIntas Pharma. (Biopharma Div.)

Mr. Anirudh SahooM. Pharma. (Pharma. Biotech.)

Manager, Biocon Research.

Dr. Sailendra GoswamiPhD (Pharmacology)

CEO & Joint Managing DirectorVayam Research Solutions Ltd.

To know more details about our speaker profile, please visit conference page “Scientific event” of website

Basilion is overwhelmed to have presence of such honourable senior subject specialist from different organizations, who keeps their valuable time from busy schedule and coming to the National Scientific Conference as a Keynote Speaker & subject expert panellist to share their vast experience in clinical research.

https://www.basilion.com/scientific-events.html

Mr. Arvind KukretyDeputy Drugs Controller (India)

Ahmedabad (Zonal office), CDSCO

Program Co-Chair

Scientific Professionals Who Are Involved In Clinical Research And Belonging To Industry, Healthcare, Ethics Committee, Regulators, Academia, CRO, SMO & Clinical Trial Sites And Involved In Below Functioning Areas..

Why should attend?

Feasibility Assessment

Investigators

Project Management

Biostatistics

Medical Writing

Clinical Data Management

Quality Control & Quality Assurance

Regulatory Affairs

Outsourcing Projects

DSMB/ IDMC members

Review panel members

Medical Research

Drug Discovery & Development

Clinical Research Coordinators

Clinical Research Associates

Clinical Trials Sites

Ethics Committee

Business Development Team

Individual Consultants

Basilion brings all scientific professional & stakeholders from industry, CROs, SMOs, KPOs, Ethics committee, Clinical investigators along with vendors across nation and policymakers of India under one roof towards nation's goal to encourage Indian clinical research.

WHO SHOULD ATTEND ?

To update knowledge of recently published “New Drugs & Clinical Trial Rule-2019”

notified by MHFW & CDSCO.

To know regulatory vision on Indian Clinical Research

To learn insights of Regional & Multi Regional Clinical Trial

To grow and enhance the knowledge of diverse global regulatory requirements

To develop skills for strategic streamline management of Science, Ethics and Resources

To understand applications of ethical conduct of Clinical Research

To understand skill set required to excel in Pharmaceutical Industry

National Platform for professional networking of Clinical Research Community who are

from Industry, Healthcare, Ethics committee, Regulators, Clinical Trial Sites, Academia,

CROs, SMOs under a single roof.

SCIENTIFIC SESSION AGENDA

08:15 to 09:00

09:00 to 09:05

09:05 to 09:50

09:50 to 10:20

10:20 to 10:30

10:30 to 10:40

10:40 to 11:20

11:20 to 12:00

12:00 to 12:15

12:15 to 01:00

01:00 to 01:45

01:45 to 02:30

02:30 to 03:00

03:00 to 03:45

03:45 to 04:30

04:30 to 04:45

04:45 to 05:30

05:30 to 06:15

06:15

Registration & Breakfast

Opening Session & Welcome Notes

Early Phase Trials - Strategic Management of diverse regulatory requirements for Early Phase Global Clinical Trial

Speaker - Dr. Charu Gautam

Knowledge sharing on "Insights of Clinical Trial"Speaker - Dr. Rajendra Jani

Networking Break

Opening session of subject expert panel discussion & Welcome Notes

Paradigm shift of Indian Clinical Research RegulatorySpeaker - Dr. Mira Desai

Clinical Research Expert panel discussion on"Empowering clinical research science & practice from Indian perspective"

Moderator- Dr. Senish Devis

Expert Penallist - Mr. Arvind Kukrety, Dr. Rajendra Jani, Dr. Naveen Sharma, Dr. Chirag Desai

Dr. Bhashawat Chakraborty, Dr. Sailendra Goswami, Dr. Mira Desai

Analysis of SAE from regulatory perspective:Regulatory Handling & Management of Serious Adverse Event and

criteria of evaluation for compensationSpeaker - Dr. Mita Nandy

Open forum discussion

Luncheon

GxP Quiz

Feasibility assessment, Site/Country selection:"forecasting of Global Clinical Trial from Science, Ethics and Resources"

Speaker - Mr. Anirudh Sahoo

Clinical Trial Protocol Development"Multiregional regulatory compliant designing of protocol towards objective of clinical trial"

Speaker - Dr. Senish Devis

High Tea & Networking

Brainstorming Session:Group Discussion on Project Management of Global Clinical Trial

Speaker - Mr. Kapil Jhawar

Clinical Trial Outsourcing:"Outsourcing strategy, advantages, risk & challenges"

Speaker - Dr. Vinu Jose

Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT:Identifying & managing Protocol deviation, Protocol violation, RCA &

CAPA from Global Regulatory PerspectiveSpeaker - Dr. Bhaswat Chakraborty

Closeout Summary & Vote of thanks

HAPPY LEARNING!

Scientific SessionTime

Early Bird Registration

(Group)

Early Bird Registration

(Single)

Standard(Spot Registration)

Student/CRC Participation

Last Date of Registration

09 May 2019 09 May 2019 11 May 2019 11 May 2019

1750 + 315= 20655000 + 900 = 59004000 + 720 = 47203750 + 675 = 4425

Registration Fees (INR)

Basic + 18% GST= Total

Registration Fees

Notes-

thGroup discount (Premium): Register 10 from your company and receive the 11 free!

· The Registration fees shall include refreshment breaks and Luncheon

· Accommodation shall be borne by the participants only.

· Students must have to present valid id proof issued by college

Cancellation Policy:

Payment Proces

· Cancellation must be in writing and received by 30 Apr 2019. After 30 Apr 2019 no any cancellation request shall be

entertained.

· 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.

· Basilion reserves the right to alter the venue, if necessary.

· If an event is cancelled, Basilion shall refund full registration fees only.

· Fill the online "Confirm your Registration" Form for participation confirmation; select the mode of Payment & Submit the

Form.

· Select the number of participants.

· Registration done by organization- Name of each participant his/her contact number and email id shall be mentioned

while address of organisation needs to be mentioned.

· Registration done by individual candidate shall have write "NA" in place of name of organization. While other details like

name, contact number, address shall be written.

· The copy of submitted form shall be sent to your mail id.

· The registration committee shall send you the Invoice towards which payments shall be made by multi-city cheque/ Draft

or online transfer.

· Make the Online payment or Draft/Multi-City Cheque.

· Email us the receipt of online payment or scan copy of Draft/Multi-City Cheque. Send us Draft/ Multi-City Cheque through

fast track courier.

· Once the fees received by the committee, participation confirmation receipt shall be send to you by email.

Multi City Cheque/DraftFilled application form along with draft/cheque

made payable to "Basilion Healthcare And

Research" should be sent to:

Basilion Healthcare And Research; C/O, Mr. Darshan DavethWest Gate, Block-B, 1801 (The address), 18 floor,

Near YMCA Club,Ahmedabad-15, India

Contact No. – 08866809679

Mail id- info@basilion.com

Account Name - Basilion Healthcare And Research

Account No. - 50200034972671

Bank Name - HDFC Bank

Branch Name - Nakshtra Building, Maninagar, A’bad-380008

RTGS/ NEFT IFSC Code: HDFC0000300

MICR Code - 380240008

Swift Code - HDFCINBB

Online Payment Details

Clinical Trials Day is celebrated around the world in May to recognize the day that James Lind started what is often considered the first randomized clinical trial on deadly

thdisease scurvy on 20 May 1747.

Do join us to celebrate & commemorate th

"International Clinical Trials Day- 20 May" with us in a unique way at Ahmedabad on

thSaturday, 11 May 2019.

Let's join hands together and represent India a Science, Ethics

and Resources empowered destination for Clinical Research across globe.

Conrm your participation... Registration closes soon...

Hurry...

Limited Seats Only

Ahmedabad City Attraction - The 600 years old city of Ahmedabad

(1411 A.D) has it all to be the first city in India to be Inscribed in UNESCO's

World Heritage City list of 2017.

Bhadra Fort Sabarmati Ashram Sidi-Saiyyad Mosque

Jama Masjid

Adalaj Stepwell

Statue of Unity - 198 km far from A'bad

Kankaria Lake

Science City

Mount abu - 228 km far from A'bad

Gir Forrest - 348 km far from A'bad

Akshardham ( Gandhinagar )

Hathisingh Jain Tample

Udaipur-City of Lake - 268 km far from A'bad

AHMEDABAD - GUJARAT

A global independent services

provider of Healthcare & Research

based on Scientific Knowledge and

Process.

Scientific Services offers by Basilion are:

1. Product development strategic analysis

2. GXP training

3. Medical & Scientific Writing

4. BE Study Management

5. Clinical trial site management

6. Global Regulatory and Medical Affairs

7. Translation services

8. Pharmacovigilance

9. Independent Monitoring & Quality Assurence

10. Centralize DSMB for MRCD

11. CDM & Biostats

Basilion Healthcare And Research; Corporate Office:West Gate, Block-B,

th1801 (The address), 18 floor,Near YMCA Club,Ahmedabad-15, India,

Feel free to Contact us :Contact No.: +91 8866809679 / 079 - 66118236Mail id : info@basilion.comwebsite:www.basilion.com

Supporter: