Philippine Clinical Research Professionals, Inc

Sponsored by:

TRILOAD

GENERAL ASSEMBLY 2011

10 Years of PCRP : Akdang Bayan Inc. Then, Now and Beyond

In partnership with:

December 07, 2011 8:00am – 5:30pm

Unilab Bayanihan Center JY Campos Hall B; Conference Rooms A, E & F No. 8008 Pioneer Street, Brgy. Kapitolyo, Pasig City 8:00-9:00 Arrival and Registration

9:00-9:10 Invocation Dr. Errol Casiano Board of Directors 2011-2013 National Anthem Ms. Vianca Uy OFFICERS Conrado D. Vidad Jr. President Opening Energizer Ms. Tippi Chua and Ms. Nancy Mendiola, Hosts Jeannette G. Sy Vice President 9:10-9:15 Welcome Address/ Introduction of Keynote Speaker Mr. Conrado Vidad Jr. Marissa M. Laureta PCRP President Secretary

9:15-9:45 Keynote Address: “Directions on Clinical Trial Conduct in Donnamay D. Calvendra the Philippines: Perspective from PCHRD” Treasurer Dr. Jaime Montoya Abishai Faye D. Limpin Executive Director, PCHRD Auditor

“Q and A Session” Maria Cecilia L. Castillo Moderator: Public Relations Officer Ms. Jeannette Sy PCRP Vice President COMMITTEE HEADS

9:45-10:45 Panel Discussion: 10 Years of GCP in the Philippines Arnaldo F. Ocampo Panel of Reactors: Organizational Development Dr. Cynthia Valencia Errol M. Casiano Head Coordinator, Research Grants Administration Office, Policy Making U.P. Manila Al Ryan L. Baniqued Dr. Benjamin Sablan Jr. Scientific Affairs Coordinator for Training, Office of the Deputy Director for Health Operation, U.P. Philippine General Hospital Almira T. Daguman Ways and Means Prof. Edlyn Jimenez Catherine E. Fabros Secretariat Coordinator, U.P. Manila Research Ethics Ethics Board EX-OFFICIO MEMBER Grace R. Mendoza Immediate Past President Ms. Rowena Miranda Associate Director, Learning and Development - Quintiles 12:30-13:30 LUNCH Philippines Inc. 13:30-14:00 Scientific and Technical Breakout Sessions Moderator:  Rm A: SMO Services (Sponsored by Fortitude) Ms. Grace Mendoza  Rm E: Ensuring Quality in Language Translation PCRP Immediate Past President and Associate Director, (Sponsored by Akdang Bayan) Parexel Clinical Research (Phil) Ltd. Corp.  Rm F: Quality Aspects in Laboratory (Sponsored by Hi-Precision) 10:45-11:00 The Dasmariñas Declaration Dr. Charles Yu 14:00-14:45 PCRP and Clinical Trials in the Philippines: Then & Now Lead Convener and VP, La Sallian Mission Mr. Rodmar Pulido Regional Business Development Manager, Gleneagles CRI 11:00-11:30 A Call to Action for PCRP: Developing a Framework for Self Pte Ltd Regulation  Opportunities for Self Regulation Directions of PCRP: Now & the Future Mr. Conrado Vidad Jr. Ms. Grace Mendoza PCRP President PCRP Immediate Past President and Associate Director,  Role of PCRP and Call to Action Parexel Clinical Research (Phil) Ltd. Corp. Ms. Grace Mendoza PCRP Immediate Past President 14:45-15:15 Committee Meetings  Rm A: Organizational Development 11:30-12:30 Breakout Sessions (Topics / Moderators)  Rm E: Scientific Affairs  Rm F: Ways and Means  Approval of Clinical Trial  JY Campos Hall: Policy Making Ms. Marissa Laureta, PCRP Secretary  Supply of Investigational Product 15:30-16:30 Plenary Presentation: Establishing Areas for Self- Mr. Al Ryan Baniqued, PCRP Chair - Scientific Affairs  Amendments to Approved Clinical Trial Regulation Ms. Maria Cecilia Castillo, PCRP Public Relations 16:30-17:15 Celebrating Ten Years of PCRP Officer  Continuing Review and Assessment of Clinical 17:15-17:30 Closing Remarks Trials Mr. Conrado Vidad Jr. Mr. Arnaldo Ocampo, PCRP Chair - Organizational Development PCRP President  Pharmacovigilance Requirements Dr. Errol Casiano, PCRP Chair - Policy Making  Regulation of Sponsor, Investigator, and IRB Qualification Ms. Abishai Faye Limpin, PCRP Auditor Ms. Rowena Miranda Associate Director, Learning and Development - Quintiles 12:30-13:30 LUNCH Philippines Inc. 13:30-14:00 Scientific and Technical Breakout Sessions Moderator:  Rm A: SMO Services (Sponsored by Fortitude) Ms. Grace Mendoza  Rm E: Ensuring Quality in Language Translation PCRP Immediate Past President and Associate Director, (Sponsored by Akdang Bayan) Parexel Clinical Research (Phil) Ltd. Corp.  Rm F: Quality Aspects in Laboratory (Sponsored by Hi-Precision) 10:45-11:00 The Dasmariñas Declaration Dr. Charles Yu 14:00-14:45 PCRP and Clinical Trials in the Philippines: Then & Now Lead Convener and VP, La Sallian Mission Mr. Rodmar Pulido Regional Business Development Manager, Gleneagles CRI 11:00-11:30 A Call to Action for PCRP: Developing a Framework for Self Pte Ltd Regulation  Opportunities for Self Regulation Directions of PCRP: Now & the Future Mr. Conrado Vidad Jr. Ms. Grace Mendoza PCRP President PCRP Immediate Past President and Associate Director,  Role of PCRP and Call to Action Parexel Clinical Research (Phil) Ltd. Corp. Ms. Grace Mendoza PCRP Immediate Past President 14:45-15:15 Committee Meetings  Rm A: Organizational Development 11:30-12:30 Breakout Sessions (Topics / Moderators)  Rm E: Scientific Affairs  Rm F: Ways and Means  Approval of Clinical Trial  JY Campos Hall: Policy Making Ms. Marissa Laureta, PCRP Secretary  Supply of Investigational Product 15:30-16:30 Plenary Presentation: Establishing Areas for Self- Mr. Al Ryan Baniqued, PCRP Chair - Scientific Affairs  Amendments to Approved Clinical Trial Regulation Ms. Maria Cecilia Castillo, PCRP Public Relations 16:30-17:15 Celebrating Ten Years of PCRP Officer  Continuing Review and Assessment of Clinical 17:15-17:30 Closing Remarks Trials Mr. Conrado Vidad Jr. Mr. Arnaldo Ocampo, PCRP Chair - Organizational Development PCRP President  Pharmacovigilance Requirements Dr. Errol Casiano, PCRP Chair - Policy Making  Regulation of Sponsor, Investigator, and IRB Qualification Ms. Abishai Faye Limpin, PCRP Auditor