7th asian conference on pharmacoepidemiology · international society of pharmacoepidemiology...

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International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated to promoting pharmacoepidemiology, the science which relates to the use, effectiveness, value and safety of pharmaceuticals. ISPE members from 53 countries are drawn from the various scientific disciplines involved in studying drugs and ISPE provides an international forum for sharing knowledge and scientific approaches within the science of pharmacoepidemiology. The Event e ACPE is meeting for the seventh time in Oct 2012. e goal of this conference is to provide a platform for com- munication among stakeholders from academia, industry and government to share their experiences and concerns on drug safety and effectiveness issues. e theme of the conference is ‘Medication Safety and Effectiveness: Building evidence through good pharmacoepidemiology practice’. Both national and international professional experts will address key topics in this field. In addition, both podium and poster presentations of submitted research work from India and around the world will be discussed. Join with colleagues in both educational and social events where healthcare sciences and improved public health are the focus. JSS University (JSSU) JSS University, offers graduate, post-graduate and research programs in the field of Medical, Dental and Pharmaceutical Sciences. With four constituent colleges under its wing, the University is the largest education provider and employer in the region. In addition to being committed towards imparting high quality professional education, the university is also involved in creating applicable knowledge to support social and economic advancement. Indian Society of Clinical Research (ISCR) ISCR is a not for profit organization of clinical research professionals from India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics. The Hosts www.acpe-india.org 26 - 28 October 2012, Bengaluru – India Medication Safety and Effectiveness: Building evidence through good pharmacoepidemiology practice 7 th Asian Conference on Pharmacoepidemiology

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Page 1: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

International Society of Pharmacoepidemiology (ISPE)

ISPE is a non-profit international professional membership organization dedicated to promoting

pharmacoepidemiology, the science which relates to the use, effectiveness, value and safety of pharmaceuticals. ISPE members from 53 countries are drawn from the various scientific disciplines involved in studying drugs and ISPE provides an international forum for sharing knowledge and scientific approaches within the science of pharmacoepidemiology.

The EventThe ACPE is meeting for the seventh time in Oct 2012. The goal of this conference is to provide a platform for com-munication among stakeholders from academia, industry and government to share their experiences and concerns on drug safety and effectiveness issues. The theme of the conference is ‘Medication Safety and Effectiveness: Building evidence through good pharmacoepidemiology practice’. Both national and international professional experts will address key topics in this field.

In addition, both podium and poster presentations of submitted research work from India and around the world will be discussed. Join with colleagues in both educational and social events where healthcare sciences and improved public health are the focus.

JSS University (JSSU)

JSS University, offers graduate, post-graduate and research programs in the field of Medical,

Dental and Pharmaceutical Sciences. With four constituent colleges under its wing, the University is the largest education provider and employer in the region. In addition to being committed towards imparting high quality professional education, the university is also involved in creating applicable knowledge to support social and economic advancement.

Indian Society of Clinical Research (ISCR)

ISCR is a not for profit organization of clinical research

professionals from India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.

The Hosts

www.acpe-india.org

26 - 28 October 2012, Bengaluru – India

Medication Safety and Effectiveness: Building evidence through good pharmacoepidemiology practice

7th Asian Conference onPharmacoepidemiology

Page 2: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

Introduction to Pharmacoepidemiology Workshop

09:00 AM Morning coffee and welcome09:30 AM Educational session 111:00 AM Coffee break11:15 AM Educational session 212:45 PM Lunch02:00 PM Educational session 303:30 PM Coffee break03:45 PM Educational session 405:00 PM Discussion and close

Saturday, 27th OctOber 2012 (conference Program)

08:00 AM Welcome coffee8:00 AM Welcome coffee8:30 AM Opening formalities9:00 AM Keynote Address 1: ‘Safety and effectiveness through good pharmacoepidemiology practice’10:00 AM Coffee break10:30 AM Symposium 1:‘Benefits and Risk Analysis – Concepts and Applications’ Symposium 2:‘Comparative effectiveness research’12:00 PM Lunch + Poster session 102:00 PM Contributed paper session 1 and Contributed paper session 203:30 PM Coffee Break04:00 PM Contributed paper session 3 and Contributed paper session 405:30 PM Close of sessions07:30 PM Gala Dinner

Sunday, 28th OctOber 2012 (conference Program)

08:00 AM Morning coffee8:30 AM Contributed paper session 5 AsPEN Symposium10:00 AM Coffee break10:30 AM Symposium 3: ‘Best practice in drug utilization research’ Symposium 4: ‘Current Challenges in Pharmacovigilance’12:00 PM Lunch + Poster session 22:00 PM Contributed paper session 6 and Contributed paper session 73:30 PM Coffee break4:00 PM Keynote Address 2: ‘Good pharmacoepidemiology practice in Asia, Why? And How?’5:00 PM Concluding remarks, Awards and ACPE8 announcement05:15 PM Close

advanced topics in Pharmacoepidemiology

01:00 PM Coffee and welcome01:30 PM To be announced02:15 AM To be announced03:00 PM Coffee break03:30 PM To be announced04:15 PM To be announced05:00 PM Discussion and close

The Program

FrIday, 26th OctOber 2012 (educational Sessions)

Page 3: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

Hotel Sheraton at Brigade GatewayBengaluru, India, 26/1, Dr. Rajkumar Road, Malleshwaram, Rajaji Nagar, Bengaluru -560055

• Conference Registration details and credit-card payment arrangements are available on the conference website: www.acpe-india.org

• Indian nationals can pay the fee by demand draft payable to ‘JSS University Seminar Account’ at Mysore

• Drafts should be mailed to Organising Secretary, ACPE 7, JSS College of Pharmacy, S S Nagara, Mysore- 570015

Conference Early Registration Late Registration27 - 28 October 2012 On/Before 15th August 2012 Later than 15th August 2012

Student 3000 INR/ 62 USD 4000 INR/ 82 USDAcademic/Government 4000 INR/ 82 USD 5000 INR/ 103 USDIndustry 6000 INR/ 124 USD 8000 INR/ 164 USD

*Educational Session 26th October, 2012

Student 1200 INR/ 25 USD 1500 INR/ 31 USDAcademic/Government 1500 INR/ 31 USD 1800 INR/ 37 USDIndustry 3000 INR/ 62 USD 4000 INR/ 82 USD

Who should attend?• People working in the medical affairs, drug

safety and pharmacoepidemiology depart-ments of CRO/Pharma Companies

• Faculty and Postgraduate students of Medical, Dental, Pharmacy institutions and Pharm D students interested in the area of Pharmacoepidemiology and healthcare improvement

• Members of Government/Regulatory, Research institutions and NGOs involved in Public Health

Travel and AccommodationBengaluru is well connected by air, rail and road. Taxi and other public transport facilities are available from airport, train and bus station. A variety of accommodation facilities are available. For more details, please visit the conference website: www.acpe-india.org

Th eVenue and Registration

Note : Fees is inclusive of 10% tax, applicable on international cards

* Educational session on 26th October, 2012 includes two parallel tracks, Pharmacoepidemiology Basics and Advanced Pharmaepidemiology Course. Pharma-coepidemiology Basics track will comprise full day education sessions and is focused at beginners and students to impart knowledge on basic concepts, methods in drug efficacy and safety research including risk management. Advanced pharmacoepidemiology course will include half a day (post lunch) educational sessions and would be of particular interest to professionals from industry and academia who have experience in the field.

https://www.starwoodmeeting.com/StarGroupsWeb/booking/reservation?id=1203077969&key=D685A

Page 4: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

Conference Speakers

Key note Speakers

brian StromProfessor of Public Health and Preventive MedicineDepartment of Biostatistics and Epidemiology,Center for Clinical Epidemiology and Biostatistics Perelman School of Medicine at theUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA

yea-huei Kao yangProfessor/DirectorInstitute of Clinical Pharmacyand Pharmaceutical SciencesHealth Outcome Research Center,National Cheng Kung University, Tainan, Taiwan

Stella blackburnPresident, ISPEEuropean Medicines Agency,Risk Management Development and Scientific Lead,London, United Kingdom

niteesh choudhryAssociate Professor, Harvard Medical School,Division of Pharmacoepidemiology andPharmacoeconomics,Department of Medicine, Brigham and Women’sHospital, Boston, Massachusetts, USA

nilima KshirsagarNational Chair in Clinical PharmacologyIndian Council of Medical Research, New Delhi, IndiaDean, ESI-PGIMSR, MGM Hospital, Mumbai,Maharashtra, India

cecilia Stålsby-Lundborg Professor, Head of DivisionDiv of Global Health, IHCAR,Dept. of Public Health Sciences,Karolinska Institutet, Nobelsväg 9,Stockholm, Sweden

andy StergachisProfessor of Epidemiology & Global Health,Director, Global Medicines Program, School ofPublic Health, University of Washington,Seattle, Washington, USA

John talbotSenior Lecturer, Pharmacovigilance, University of Hertfordshire,Hatfield, United Kingdom

Sujith J chandyProfessor of Clinical Pharmacology & Head, Pharmacy,Christian Medical College and Hospital, Vellore, Tamilnadu, India

Flora haaijer-ruskampChair, Professor in Drug Utilisation Studies,Dept of Clinical Pharmacology andSHARE (Health Research, GraduateSchool of Medical Sciences), University of Groningen, The Netherlands

Kiyoshi KubotaProfessor of PharmacoepidemiologyDepartment of Pharmacoepidemiology, Faculty of Medicine,University of Tokyo, Japan

Soko SetoguchiAssociate ProfessorDuke University (US) and University of Tokyo (Japan),Duke Clinical Research Institute, Durham,North Carolina, USA

Walter StrausGlobal DirectorScientific Affairs - Vaccines, Merck & Co. Inc.,Pennsylvania, USA

Songlin XueVice President,Pharmacovigilance, Takeda Pharmaceuticals,Illinois, USA

Symposium and educational Session Speakers

Page 5: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

Invitation for Abstracts Submission

Instructions for preparing abstracts1. Please format your Abstract as a ‘Word’ document. The abstract must be single-spaced and in upper and lowercase letters. The

text must not exceed 500 words including title, author details and key words. Abstracts should follow the following format: Aim/Objective, Methods, Results and Conclusion. List not more than four key words related to your research. Tables, graphs, and charts are NOT permitted in abstracts.

2. The title of the abstract must be in upper case. The title should be specific to the content. Use short titles and standard abbreviations (expand at its first instance). Underscore the presenting author’s name and affiliation. Avoid reference to institution names, locations or funding sources in the body of the abstract.

3. All abstracts must be submitted in English only. Please carefully check all text for errors before submission, as the quality of your submission may affect the outcome of the reviewers’ scoring of your abstract. No edits for typing, spelling, or grammatical errors will be possible after Abstracts have been submitted.

4. Please indicate on your Abstract ‘word’ document your preference for mode of presentation: • Podium/Oral • Podium/Oral OR Poster • Poster

5. You may select the presentation type you prefer, however the reviewers’ decision will be final in this regard.

abstract review Process and Presentation1. In accordance with ISPE policies and procedures, all submitted Abstracts will be anonymised as to author and submitting

institution, and then reviewed by multiple Reviewers.

2. The Conference organizers will assign accepted Abstracts either to oral/podium or poster presentation based on the overall Reviewers’ score as well as the authors’ expressed preference. Notification of acceptance or non- acceptance will be sent by email to the submitting author by 1st August 2012.

3. Only the submitting author will be notified of acceptance or non-acceptance, and it is the submitting author’s responsibility to notify all other authors of the outcome of the reviewers’ decision.

4. For all accepted Abstracts, the details of podium/oral presentation (PowerPoint presentation) and poster presentation (poster size, format, style and layout etc) will be communicated to presenting authors respectively. The authors of accepted Abstracts for podium/oral presentation must submit PowerPoint slides to the Conference Secretariat not later than 1st October 2012.

5 The presenting author must be registered for the conference to be able to present the Abstract. All accepted Abstracts will be published in the conference booklet if the presenting author has registered for conference attendance before 15th October 2012.

The conference invites Abstracts for both oral/podium, and poster presentation at ACPE7. Students, academicians and professionals from practice, industry, and academic institutions involved in study of relevant topics in pharma-coepidemiology are invited to consider submitting Abstracts for presentation and discussion at the meeting.

1. Pharmacoepidemiology and Pharmacovigilance methods2. Drug utilization studies3. Post-marketing drug effectiveness and safety evaluation4. Drug safety and risk management5. Prevention and treatment of drug-induced diseases6. Pharmacogenomics research and drug safety7. Adherence

8. Evidence-based medicine/pharmacy9. ‘Rational’ drug use10. Prevention of medication errors and drug misuse/abuse 11. Rare disease and orphan medicines13. Pharmacoepidemiology and traditional medicines 14. Pharmaceutical policy and administration15. Other related fields

Important dates:• Deadline for Abstract Submissions: July 01, 2012 • Notification of Acceptances: august 01, 2012

Suggested topic areas for abstract submission include:

All abstracts must be submitted electronically using the on-line submission portal on the conference website, by July 01, 2012

Page 6: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

Name Designation & Institutional affiliation

Ulf Bergman Professor, Senior Medical Officer, Centre for Pharmacoepidemiology, Karolinska Institutet and Division of Clinical Pharmacology, Karolinska University Hospital, Stockholm, Sweden

Pipasha Biswas Chairperson, Special Interest Network Consultation Committee, Drug Safety & Pharmacovigilance; Faculty of Pharmaceutical Medicine, Royal College of Physicians London, UK; Director and QPPV, Symogen, London, UK

Stella Blackburn President-Elect, ISPE

Krathish Bopanna President, Indian Society of Clinical Research; President & Executive Director, Semler Research Centre Pvt Ltd, Bengaluru, India

Kin-Wei Arnold Chan

Senior Scientist, i3 Drug Safety/Harvard School of Health Public

Chih-Ying (Natasha) Chen

Postdoctoral Fellow/Research Fellow Brigham and Women’s Hospital/Harvard Medical School, Boston MA, USA

Niteesh K Choudhry Associate Professor, Harvard Medical School and Brigham and Women's Hospital, Boston MA, USA

Debashish Dey Senior Medical Advisor, Global Patient Safety Eli Lilly & Company

Mark Epstein Executive Secretary, ISPE, Washington DC, USA

Stephen Evans Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine, UK

Yea-Huei Kao Yang Professor/Director, Institute of Clinical Pharmacy and Pharmaceutical Sciences, Health Outcome Research Center National Cheng Kung University, Tainan, Taiwan

Nilima Kshirsagar National Chair in Clinical Pharmacology, Indian Council of Medical Research, New Delhi, India; Dean, ESI-PGIMSR, MGM Hospital, Mumbai, India

Kiyoshi Kubota Professor of Pharmacoepidemiology, Department of Pharmacoepidemiology, Faculty of Medicine, University of Tokyo, Japan

Frank May Service Director, Drug and Therapeutics Information Service, Adelaide, South Australia

Byung-Joo Park Professor and General Director, Chairperson, Department of Preventive Medicine, Seoul National University College of Medicine/ General Director; Korea Institute of Drug Safety & Risk Management, Korea

Gurumurthy Parthasarathi

Professor, JSS College of Pharmacy, JSS University, Mysore

Nancy Santanello President, ISPE

Soko Setoguchi Associate Professor, Duke University (US) and University of Tokyo ( Japan), Duke Clinical Research Institute, Durham NC, USA

Walter Straus Global Director for Scientific Affairs – Vaccines, Merck & Co., Inc., North Wales PA, USA

Bhojraj Suresh Vice Chancellor, JSS University, Mysore; President, Pharmacy Council of India

Songlin Xue Senior Vice President and Global Head of Pharmacovigilance, Takeda Pharmaceuticals International, Inc. Deerfield Illinois, USA

Wei Zhou Regional Director and Head, Epidemiology Asia Pacific Unit, Merck Research laboratories

International Steering Group

Page 7: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

Local Organising Committee

Responsibility Name Designation & Institutional affiliationChairman Dr. B. Suresh Vice Chancellor, JSS University, Mysore

President, Pharmacy Council of India [email protected]

Co-Chairman Dr. Krathish Bopanna

President & Executive Director, Semler Research Centre, Bengaluru President, Indian Society of Clinical Research [email protected]

Organizing Secretary

Dr. G. Parthasarathi Professor, JSS College of Pharmacy, JSS University, Mysore [email protected]

Scientific Committee

Dr. M. Ramesh Professor, JSS College of Pharmacy, JSS University, [email protected]

Treasurer Mr. Raghunandan Associate Professor, JSS College of Pharmacy, JSS University, Mysore [email protected]

Venue Dr. Radhika Bobba Director, Anhvita BioPharma Consulting, Bengaluru [email protected]

Registration Dr. Adepu Ramesh Professor, JSS College of Pharmacy, JSS University, [email protected]

Transport Ms. Thanuja Naidu Country head, Pharm-Olam, Bengaluru [email protected]

Volunteers Dr. Anand Vijaykumar

Professor, JSS College of Pharmacy, JSS University, [email protected]

Accomodation Dr. Ponnushankar Professor, JSS College of Pharmacy, JSS University, [email protected]

Dr. H. Basavanagowdappa Prof. & Principal, JSS Medical College, Mysore

Dr. B. Nandlal Prof. & Principal, JSS Dental College, Mysore

Dr. H. G. Shivakumar Prof. & Principal, JSS College of Pharmacy, Mysore

Dr. K. Elango Prof. & Principal, JSS College of Pharmacy, Ooty

Dr. Mruthyunjaya Kulenur Registrar, JSS University, Mysore

Dr. P A. Kushalappa Director - Academics, JSS University, Mysore

Sri G. N. Singh Drug Controller General (India) Central Drugs Standard Control Organisation, New Delhi

Dr. B. R. Jagashetty Drugs Controller for the State of Karnataka, Bengaluru

Mr. Ragurama Bhandary Additional Drugs Controller for the State of Karnataka, Bengaluru

Dr. Y. K. Gupta Prof. & Head, Dept. Pharmacology, All India Institute of Medical Sciences, New Delhi

Dr. Arun Bhat President, ClinInvent Research Pvt Limited, Mumbai

Dr. C. Adithan Prof. & Head, Dept. of Pharmacology, Jawaharlal Institute of Post Gradu-ate Medical Education & Research, Puducherry

Dr. Urmila Thatte Head, Dept. of Clinical Pharmacology, TN Medical College and BYL Nair Hospital, Mumbai

Dr. T. V. Narayana - Director, Vikas Institute of Pharmaceutical Sciences, Rajahmundry - Chairman, Educational Division, Indian Pharmaceutical Association, Mumbai

Dr. Suresh Bowalekar Managing Director, Pharma Net Clinical Services, Mumbai

Dr. T. K. Ravi Prof. & Principal, College of Pharmacy Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore

Dr. Divakar Goli Prof. & Principal, Acharya & BM Reddy College of Pharmacy Bengaluru

Dr. Guru Prasad Mohanta Professor, Department of Pharmacy, Annamalai University, Chennai

Bindhya Cariappa Sr. Director – Asia Pacific & MEA ClinTec International Pvt Limited, Bengaluru

Indian Advisory Board

Page 8: 7th Asian Conference on Pharmacoepidemiology · International Society of Pharmacoepidemiology (ISPE) ISPE is a non-profit international professional membership organization dedicated

26 - 28 October 2012, Bengaluru – India

Medication Safety and Effectiveness: Building evidence through good pharmacoepidemiology practice

7th Asian Conference onPharmacoepidemiology

www.acpe-india.org

For further information please contact

dr. G Parthasarathi, Organising Secretary, ACPE 7JSS College of Pharmacy, JSS University, S S Nagara MYSORE - 570 015, India• Telephone : +91-821-2548356 • Fax : +91-821-4253628 • E-mail : [email protected]