drug development workshop - brochure

8/4/2019 Drug Development Workshop - Brochure

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First time in India First time in India

First

Time inIndia

Two Days Workshop on

Drug Development Mouse to Man

First time inIndia

Two Industry GiantsComing Together

With DiverseExperience

Life timeExperience

Shared

High EndedPractical

ApplicationsDiscussed

Who Should Attend the Workshop

Professionals working in

- Drug discovery companies- Clinical research organizations- Pharma companies- Independent research workers- Clinical Pharmacologists- Preclinical pharmacologists

Faculty of - Government and Non Government

regulatory bodies and accreditingagencies

- Medical, Dental, Pharmacy,Veterinary, Biotechnology andother life sciences academicinstitutions

- Clinical research and preclinicalresearch academies

Students of above mentioned areas.

Dates: November 25-26, 2011

Venue: Conference Hall, St. John's AuditoriumComplex, John's National Academy of Health SciencesJohn Nagar, Koramangala, Bangalore.

Knowledge Partners Organizing Partner

Dr. K S Rao Dr. Shiva Murth N


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Topics for Day 1 Dr. KS Rao9.00 am to 6.00 pm, with two coffees and one lunch breaks

Topics for Day 2 Dr. Shiva Murthy N9.00 am to 6.00 pm, with two coffees and one lunch breaks

Sources of Drugs Lead Identification

- Herbal- Chemical- Metal- Pharmacogenomics- Bioinformatics- Structure Activity Relationship

Principles of Toxicology Pharmacokinetics and Drug Metabolism Good Laboratory Practices (GLP) Preclinical Toxicology

- Acute Toxicity- Subacute Toxicity- Chronic Toxicity- Genotoxicity- Reproductive Toxicity- Carcinogenicity

Risk Assessment Regulatory Affairs IND, NDA, ANDA Approval Process

Study Designing Basics of Statistics Clinical Research Phases Micro-dosing, Phase 1, 2,

3, 4, Pharmacovigilance, Post Marketing Trials Ethics in Clinical Research Documentation in Clinical Research Pharmacy Management in Clinical Research Volunteers and Vulnerable Volunteers

Clinical Practice Vs Clinical Research Can they becombined, how? Quality Assurance Fraud and Misconduct Clinical Operations Challenges Latest Tragedy in New Drug Development - TG1412

Lessons learnt form this event

Two Days Workshop on Drug Development Mouse to Man (November 25-26, 2011)

Introduction: Every drug paper or seminar starts with the age old statement that a typical drug development costs around a Billion US dollars. It is nowthe time we put such statements to rest and think fresh and find out why all of us have accepted such statements as facts for tomorrow without evenquestioning it.

In the past, most scientists have worked in Silos. In addition, many scientists have not learnt to understand other related allied sciences which areinvolved in drug development. This lack of understanding or any effort to learn allied sciences on the part of the individual scientists, have made thedrug development, a magic than a scientific discipline.

Our objective in this current workshop (and hopefully in future such workshops) is to open the iron curtain and train new generation of scientists to learncross disciplines, so that everyone has a sound understanding of all aspects of drug development. This level of understanding helps to question and evenunderstand our colleagues language in other related sciences involved in drug development. The planned two day workshop covers an unprecedentedbreadth and more importantly the depth of science involved in drug development. This will liberate each one of you to think out of the box and willenable you to march on to a new path to drug development to reduce the cost, since you will not be in the dark on other allied disciplines involved indrug development.


Office Address

InvenStar* Pharma Services Pvt Ltd

No. 57, Keshava Nilaya, 4 th Main,Kothanur Dinne, JP Nagar 8 th Phase, Near Water Tank,

Bangalore-560076, Karnataka,India

Contact for Participation and Sponsoring the event:Ms. Sowmya Nataraj BE, PGDSE.

Managing DirectorInvenStar Pharma Services Pvt Ltd

[email protected] [email protected] No. +91 8884328277

Preferred method of Communications Email orPhone or By post/courier

Method of Payment

- DD/Cheque: Drawn in the name of InvenStar Pharma Services Pvt LtdPayable at Bangalore, India

- Bank Transfer Account Name Invenstar Pharma

Services Pvt LtdAccount Number - 911020024934218Bank Address Axis Bank, JP Nagar, Blore


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Two Days Workshop on Drug Development Mouse to Man (November 25-26, 2011)

REGISTRATION FORM

Please check the applicable category:

Industry Non-Industry Student

PLEASE PRINT ALL INFORMATION CLEARLY

Degrees: _______________________________________________ Dr. Mr. Ms.

Last Name (Family Name):_______________________________________________________

First Name: ___________________________________________________________________

Job Title:_________________Affiliation (Company):___________________________________

Address (Please write your address in the format required for delivery to your country.)

_________________________________ Business Address Home Address _____________________________________________________________________________

___________________________Postal Code___________ City Country___________________

Telephone Number_____________ Fax Number______________ Mobile Number____________

Email (Required f or confirmation)___________________________________________________Sign/Date________

IF MAILING THIS FORM, PLEASE PROVIDE A COPY OF REGISTRANTS BUSINESS CARD.

Accommodation: We have tied up with Bluemoon Shelters, Bangalore(www.bluemoongroup.in). They have agreed to provide subsidized accommodationexclusively for our participants. Options are as below:- Twin sharing basis, Non A/C Room - Rs.850 per person inclusive tax- Single occupancy, Non A/C Room - Rs.1100 per person inclusive taxCost of both types includes Complimentary Breakfast and Wifi connection

Interested participants can get in touch directly for their reservations: +91 8025716999/ 09739711999, [email protected]

Organizers reserves the right to alter the venue, if necessary. If an event is cancelled, organizers are not responsible for any airfare, hote l or other costs incurred by registrants.

Cancellation Policy: On or Before November 10, 2011Cancellations must be in wri ting and received by November 10, 2011. Registrants who do not cancel in writing by that date and do not attend the event wi ll be responsible for the full registration fee paid. Registrants areresponsible for cancelling their own hotel and ai rline reservations. If the event is cancell ed, organizers are not responsible for any airfare, hotel or other costs incurred by registrants.Upon cancellation, the administrative fee that will be withheld from refund amount is:Full meeting cancellation : Industry/Non-industry Registration = Rs 3,000 Student Registration = Rs 500

Transfer policy: If you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email or post. Name changes and substitutions must be from the samecompany or organization and are not transferable between countries.Unforeseen situations: Organizers reserve the right to make alterations to the workshop/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseenevents beyond the control of the organizers. If s uch a situation arises, we will refund your registration fee and we will try to reschedule the event.

Registration Fee ( fee includes refreshment breaks, luncheons and Participation, Certificates, study material if any). This fee does notinclude travel or hotel accommodation.

Early bird reduction: 10 % reduction on above fee. Applicable for single and twoday participation

Group Reduction: 3 or more registration from same company/Institute will get20% reduction. Max 60 participants will be allowed.


Office Address

InvenStar* Pharma Services Pvt Ltd

No. 57, Keshava Nilaya, 4 th Main,Kothanur Dinne, JP Nagar 8 th Phase, Near Water Tank,

Bangalore-560076, Karnataka,India

Contact for Participation and Sponsoring the event:Ms. Sowmya Nataraj BE, PGDSE.

Managing DirectorInvenStar Pharma Services Pvt Ltd

[email protected] [email protected] No. +91 8884328277

Preferred method of Communications Email orPhone or By post/courier

Method of Payment

- DD/Cheque: Drawn in the name of InvenStar Pharma Services Pvt LtdPayable at Bangalore, India

- Bank Transfer Account Name Invenstar Pharma

Services Pvt Ltd

Account Number - 911020024934218Bank Address Axis B ank, JP Nagar, Blore

Venue: Conference Hall, St. John's Auditorium Complex, John's NationalAcademy of Health SciencesJohn Nagar, Koramangala, Bangalore

Type Fee for One day Fee for Two days

Industry Rs. 5,500/- including tax Rs. 10,000/- includingtax

Non Industry Rs. 4,000/- including tax Rs. 7,500/- including tax

Student Rs. 2000/- including tax Rs. 4,000/- including tax


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Sponsorship Packages

Platinum Sponsor Rs. 1,50,000

- 5 Free delegates- Brand opportunity Name and logo

will be put on eventbrochures/advertisements/all internetmarketing/promotional material and onthe venue as Platinum sponsor

- Promotional literature will be insertedin all delegates kits

Gold Sponsor Rs. 1,00,000


will be put on eventbrochures/advertisements/all internetmarketing/promotional material and onthe venue as Gold sponsor


Silver Sponsor Rs. 80,000


will be put on eventbrochures/advertisements/all internetmarketing/promotional material and onthe venue as Silver sponsor


Delegate Bag Sponsor Rs. 40,000

- 1 Free Delegate- Sponsor company logo printed on eachdelegate kit. We will place the logobased on your suggestion. Finaldecision will be taken by organizers.

- Brand opportunity Name and logowill be put on eventbrochures/advertisements/all internetmarketing/promotional material and onthe venue


Delegate Lunch Sponsor Rs. 60,000

- 1 Free Delegate- Sponsor company logo on banners will

be displayed at lunch stations as lunchpartner of the event.

- Promotional Literature will be kept onlunch venue and inserted to in alldelegate kit.


Delegate Pens/Pads Sponsor Rs. 40,000

- 1 Free Delegate- Sponsor company logo printed onattractive pens and are kept on everytable and inserted in every delegate bag(provided by the bag sponsor)


Two Days Workshop on Drug Development Mouse to Man(November 25-26, 2011)


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InvenStar Pharma Services Pvt Ltd Organizing Partner

The organization was founded in 2008 and officially registered as per company act 1956 with ROC,Bangalore, Karnataka, India in January, 2011. The main services of the company are

- Training and development in clinical research, pharmacology, biostatistics and otherrelated life sciences

- Scientific research manuscript writing and other related medical writing- Consultancy in clinical research and pharmacology (development of CROs, SOPs, development of protocols, study

designs, auditing, quality assurance, clinical study site selection and monitoring- Pharma marketing Business development for pharma products both allopathic and ayurvedic products promotionMore details available in www.ipharmaservices.com

Sowmya Nataraj, Managing Director.

Sowmya (BE, PGDSE) is a professional with training and experience in corporate environment. She was trained in Ranbaxy,Fortis Clinical Research and Lotus Labs (Part of Actavis) on Clinical Data Management, Clinical Study Report writing andQuality control. She worked for 30 bio-analytical method validation reports, 20 bio-analytical reports, 10 clinical study reports inICH and ANVISA formats. She was part of the team that faced ANVISA and DCGI regulatory inspections at FCRL. Also shewas part of various sponsor audits like Ranbaxy etc. She monitored clinical part of 5 BA/BE studies for compliance with SOPs,guidelines in Lotus Labs, Chennai. She has good understanding of Clinical research and regulatory requirements of reporting.

Organizations and People involved in this WorkshopOrganizations and People involved in this WorkshopOrganizations and People involved in this WorkshopOrganizations and People involved in this Workshop

Rao Toxicology Foundation Knowledge Partner

Rao Toxicology Foundation (RTF) is headed by Dr. K.S. Rao, a Global veteran in toxicology.Objectives of the RTF are as follows:

1. Academic - Toxicology research guidance, continuing education programme, DABTProgramme, Toxicology Consultancy

2. Regulatory - Regulatory Strategy, GLP ConsultancyOffers one stop solutions and strategies for development of: Drugs, Biotech products, Vaccines, Biosimilars, Generic APIs forImpurity Qualifications, Pesticides, Food additives, Regulatory strategies and services, Full Dossier preparation

Dr. K S Rao, Chief Scientific Officer

Dr. K. S. Rao (M.V.Sc., Ph.D., DABT) is a board certified toxicologist with over 40 years of global experience in safety

evaluation development the United States. Dr. Rao has worked at Searle labs, Dow Chemical and Quintiles in US. Currently,Dr. Rao offers expert advice to clients for product development strategies, reviews protocols and reports, prepares toxicologysummaries and Dossiers for regulatory submission. He will also monitor studies, and provides continuing solutions to testingprograms in drugs/biotech, Biosimilars, API impurity qualifications, and pesticides. During the last five years he has beenmentoring hundreds of Indian scientists in toxicology and he was instrumental in bringing the Diplomate of American Board ofToxicology to India which resulted in over two dozen certified toxicologists in India. Dr. Rao has published papers andpresented over 100 papers in international seminars.

Quartesian CR Pvt Ltd Knowledge Partner

Quartesian is a Data Service specialist with global presence. They have presence in USA, UK, Ukraineand India. The CRO was launched in 2003 andsuccessfully completed 8 years of operation.Quartesian is considered as a reliable and dependable service provider in Clinical Data Management(CDM), SAS programming, Bio-Statistical consultancy services, Medical Writing (CSR) areas.Quartesian also offers high ended industry training in CDM and SAS programming through exclusive partners like Clinimindsand Avigna learning academy. More details available in www.quartesian.com

Dr. Shiva Murthy N, Director, Clinical research and Business Development:

Dr. Murthy (MBBS, MD, PGDBA) is the clinical development leader in India, has more than 10 years experience in drugdevelopment and has worked on more than 120 clinical projects. This experience includes conducting Pre-clinical trials, Phase1, 2, 3 and 4 trials, BA/BE trials and Pharmaco-epidemiology projects. Dr. Murthy has also developed clinical research andtraining departments in India for Quartesian, ICON, Fortis and Lotus. He is trained and experienced in GCP, BLS, ACLS,Clinical operations, Pharmacogenomics, Pharmacovigilance, Medical Affairs related activities. He is the member of IndianPharmacologists Society (IPS), Indian Society for Clinical Research (ISCR) and official reviewers for Indian Journal ofPharmacology. He is also an advisory board member for Clinical Trial Magnifier, an online journal published by Clinical TrialsCenter, The University of Hong Kong.


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Directions to Reach Workshop Venue

Dear Delegates,

We welcome you to Bengaluru the Garden City and IT Capital of India.

lease find below details of Workshop Venue:

Conference HallSt. John's AuditoriumSt. John's National Academy of Health Sciences,John Nagar, Koramangala, Bangalore.

How to Reach the Venue:

rom Bangalore City Railway Station:

About 10 Km; the route is via Hudson Circle- Shanthi Nagar- Hosur Road- St. John's Medical College -Koramangala.

articipants arriving by train are advised to use the pre-paid autorickshaw service available at the cityailway station. The destination is Koramangala BDA Complex. The expected fare is about Rs.100/-. Beyond0 PM or before 6 AM, the fare could be double this amount.

rom Bangalore Bus Stand:

he Bangalore Metropolitan Transport Corporation (BMTC) operates bus services from Subhash Nagar bustand (opposite the City Railway Station) to Koramangala. The route numbers are 171, 171H (Blue Colouruses), J171, 171 (Pushpak Service).

MTC also operates buses from Shivajinagar to Koramangala and the numbers are 166, 164. You will haveo alight at the Koramangala BDA Complex' bus stop, walk across the road in order to reach auditoriumpposite to complex.

rom the Bangalore International airport:

Here are the options:

Vayu Vajra bus services.

hese are Red colored A/c VOLVO buses. Board the bus BIAL 7 (bound for Koramangala). The tickets cane purchased from the conductor after you board the bus. You have to alight at Koramangala BDA Complextop. The fare is Rs.150/- and you have to pay in Indian rupees ONLY.

asy Cab taxi services.

You can make use of this service to reach directly to the hotel you booked. These are white / green coloredabs and the fare is about Rs.750/- to Koramangala. From your hotel you can ask the cab drivers to reach

Koramangala BDA complex. Walk across the road in order to reach auditorium opposite to complex.

mportant points to note: We strongly urge the international participants to carry out the exercise of ndian currency exchange at their point of embarkation itself.

Helpline Contact:

Ms. Sowmya Nataraj - 08884328277Dr. Shiva Murthy N - 08884328275Dr. K S Rao - 09620851915

drug development workshop - brochure

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