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SCIENTIFIC AND PHYSICAL COMMITTEE
2016 ANNUAL Report Julie Anne S. Odarbe and Bella Buniel 28 Feb 2016
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Members of the Committee
Contents Introduction 1 Members of the Committee 2 2016 Accomplishments 3 2017 Plans and Programs 4
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Julie Anne S. Odarbe PRO, Scientific and Physical Chair, Philippine Association of Medical Affairs Medical Device Regulatory Affairs Professionals Regulatory Affairs Leader, GE Philippines, Inc. ASEAN CoE Leader (Center for Excellence) AdProm and IRIS (Regulatory process) – GE Healthcare ASEAN 16 years in RA Experience (this includes Pharmacovigilance Reporting – local and abroad, Clinical Trial) 3 yrs in QA/QC Control 3yrs combined Product Management and Training Management, Logistics Handled drugs, biologics, food, cosmetics, devices
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Bella Rozanna Buniel Board of Director, Co-chair, Scientific and Physical Chair, Philippine Association of Medical Affairs Medical Device Regulatory Affairs Professionals RA Manager and Drug Safety Officer, B Braun Medical Supplies, Inc. (BMSPH) Compliance Officer of BMSPH, B. Braun Avitum Phils., & Therapy Management Systems 9 yrs RA experience in Pharma/Cosmetics and Medical Device. 14 yrs in Manufacturing/Plant Management 8 yrs combined Retail Management, Logistics, GMP and R&D.
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Members of the Committee
Contents Introduction 1 Members of the Committee 2 2016 Accomplishments 3 2017 Plans and Programs 4
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Scientific Committee The committee is responsible to provide structured device training program for both industry and stakeholders. It shall also partner with appropriate regulatory bodies and industry associations in carrying out capacity building programs that will benefit regulators and industry members.
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Scientific and Physical Committee
Chair: Juls Odarbe (GE Phils Inc) Co-chair: Bel Buniel (B Braun Medical) Members: 1. Reggie Patena (Medtronic) Clarice Humilde (Metropharma) Dexford Delas Llagas (J&J) Rona Dela Rosa (3M) Andrea Ero-Gonzales (Medtronic) Jona Manalili (New Marketlink) Vangie San Juan (B Braun Medical) Emegrace Milan (Boston Scientific) Che Alfonso (Marsman Drysdale)
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Members of the Committee
Contents Introduction 1 Members of the Committee 2 2016 Accomplishments 3 2017 Plans and Programs 4
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KEY ACHIEVEMENT 2016 Technical Expertise Development
Organized Special Meeting last April about E-LTO, PAIR submission and Code of Ethics in Bayanihan Hall, UNILAB. Organized 1st overnight GMM with Teambuilding in Club Balai last June 11th (2nd) GMM 2016 and 5 yrs Anniversary last Dec 14, 2016 in Crowne Plaza Ortigas
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1st GMM 2016 – Club Balai
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11th GMM, 5th yr Anniversary and Christmas Party
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AHWP 2016
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Members of the Committee
Contents Introduction 1 Members of the Committee 2 2016 Accomplishments 3 2017 Plans and Programs 4
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GMMs 12th GMM 2017 – Feb 28 Topics: 1. Adoption of Code of Ethics
2. ISO 3. Business writing training 4. FDA updates 13th GMM 2017 – Nov/Dec 2017 1. Election 2. Christmas Party 3. FDA updates/NTC requirements
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Special Training/ Workshop Topics:
( Special Training/ Workshop Topics: In-depth CSDT training (trainer from Regional colleague or Tony Low) – MDD/MD Classification (trainer from Regional colleague or Tony Low)
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PRC Accreditation Application
( PRC Accreditation Application To start to apply for the PRC Accreditation for Accredited Trainer. To include CPE units per GMM or Special trainings
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CSR ACTIVITY Benificiary: Orphanage: Hospicio Golden Acres Activities:
( CSR ACTIVITY Benificiary: Orphanage: Hospicio Golden Acres Activities: Gift giving Simple Christmas party Donations from members: Instead of having exchange gifts during Christmas party, members will donate money for the CSR (min Php )
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Thank You !
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