CURRICULUM VITAE. Full name : Novilia Sjafri Bachtiar,dr.,M.Kes. Place, Date of birth : Pekanbaru, April 9, 1969 Male / Female : Female

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1 CURRICULUM VITAE Full name : Novilia Sjafri Bachtiar,dr.,M.Kes. Place, Date of birth : Pekanbaru, April 9, 1969 Male / Female : Female Religion : Moslem Marital status : Married, with 1 daughter and 2 sons Home Address : Jl. Permana Barat I, no.31, RT05/06, Citeurep, Cimahi Utara, Kota Cimahi Indonesia Office Address :PT Bio Farma Jl.Pasteur No.28, Bandung, West Java Indonesia Phone : (+) ext Fax : (+) Educational record : Medical Science, Padjadjaran University, (UNPAD) Bandung, Post Graduate Medical Education, Padjadjaran University (UNPAD), Bandung Magister Program for Micro Biology, UNPAD May 2012 Advance Vaccinology Course (ADVAC), Pasteur Meriaux, Annecy 2016 Doctoral Program for Medicine Faculty, UNPAD Bio Farma Vaccine Institute Present Position :October 2012 Now : Head of Surveillance & Clinical Trial Division Previous Position :October Head of Clinical Trial Department 2002 May 2008 Head of Measles National Laboratory May Acting Head, Department of Clinical Trial 2001 April 2004 Staff, Department of Clinical Trial

2 Experiences : 1. WHO inter country workshop on laboratory diagnosis of measles, National Institute of Health, Nothamburi, Thailand, August 19-23, Training on Anti-Hib ELISA (Phipps Method) 3 days, RIVM, Bilthoven, The Netherlands, September 2-4, Training on Manufacture role in GCP, The International Clinical Trial Working Group, Aryaduta Hotel, Jakarta, 24 September Ethically Good Medical Practice Combating Profesional Misconduct, University of Indonesia, Jakarta, December 12-15, Workshop on Clinical Trial Design, Monitoring and Evaluation, International Vaccine Institute, Seoul, Korea, September 12-15, Council for International Organization of Medical Sciences (CIOMS/WHO) working group, 2007-now th Vaccinology Training, International Vaccine Institute, Seoul, Korea, 7-12 May Training on HI test for Influenza Antibody Titre, Biken Vaccine Institute,3-14 September Informal Consultation on Technical Specification for an International H5N1 Vaccine Stockpile, October Participated in the WHO assisted Training and Workshop on Strengthening AEFI Monitoring and Causality Assessment, 6-9 March 2008, Banten Province, Indonesia. 11. WHO Temporary Advisor for Laboratory Staff Training in Dili, Timor Leste, April Member of Indonesian Hepatitis Task Force since May Good Clinical Practice (GCP) Training Procedure and Documentation for Clinical Trial,Jakarta June 2008, The Indonesian Clinical Trial Working Group. 14. Brighton Collaboration Working Group to standardize safety standards for clinical trials of malaria and tuberculosis vaccines, March

3 15. Joint Workshop on Environmental Monitoring Clinical Assessment, and Variations Chiang Mai, February Consultative Committee of The WHO Global Vaccine Safety Blueprint Project, March WHO informal consultation for improving influenza virus vaccine selection, June Member of Indonesian Influenza Foundation, 2011-now. 19. Meeting with National Influenza Centers on Strengthening the WHO Global Influenza Surveillance Network (GISN), WHO Mediterranean Centre for Health Risk Reduction, 30 November 3 December Global Vaccine Research Forum (GVRF) Symposia, WHO, Geneva June Global Vaccine Safety Blueprint Global Vaccine Safety Meeting, WHO, Geneva September Member of Indonesian Immunization Advocacy Committee, 2011-now. 23. Global Health Product Development Forum, Bill & Melinda Gate Foundation, Seattle, May 1-3, Advance Vaccinology Course (ADVAC), Annecy, May Pharmacovigilance system master file tutorial. DIA, Washington, Sunday, January 13, Pharmacovigilance and Risk Management Strategies 2013, DIA, Washington, January 14-16, SAGE meeting, WHO, Geneva, November 5-7, Meeting on Appropriate Clinical Endpoint for 2nd Generation HPV Vaccine Trial, WHO, Geneva, November 19-20, th International Symposium on Pneumococci and Pneumococcal Diseases in Hyderabad India, March 19-13, SAGE meeting, WHO, Geneva, April 1-3, Global Health Product Development Forum, Bill & Melinda Gate Foundation, Seattle, April 22-24, Brighton Collaboration Working Group : Vasculitis Definition,2014 Now.

4 33. WHO consultation meeting on influenza vaccine for pregnant and lactation women, clinical data requirement, WHO HQ, Geneva, July 15-16, The 3 rd meeting of Global Vaccine Safety Initiative, October 13-14, 2014, Tianjin, China. 35. Advance Vaccinology Course: Symposium Building Vaccinology Expertise in South East Asia in Bandung, Indonesia on November Global Health Product Development Forum, Bill & Melinda Gate Foundation, Seattle, May 5-7, Continuing Professional Development & Competency in GCP, IVT GCP Training Course, International Vaccine Institute and Widler & Schiemann AG, September 15-16, The 4 th meeting of Global Vaccine Safety Initiative, October 14-14, 2015, Evian, Perancis. 39. Member of Measles Elimination & Rubella Control/CRS Verification Committee October now. Experience in Trials : 1. Immunogenicity and Safety of DTwP (Bio Farma) Vaccine Combined with Recombinant Hepatitis B (GCVC) Vaccine in Indonesian Children, The safety and immunogenicity of Hib (Bio Farma) vaccine in adult (Phase I), Immunogenicity and safety study of DTwP-Hepatitis B 5ug vaccine with schedules 2,3 and 4 months, primed with Hepatitis B 10ug vaccine at birth in Bali, The safety and immunogenicity of DTwP-Hepatitis B 10ug-Hib vaccine (Bio Farma) vaccine (Phase I), The Immunogenicity and safety of recombinant Hepatitis B vaccine with two different accelerated schedules in adult, The antibody response and safety after National Immunization Day with Type 1 monovalent Oral Polio Vaccine (mopv1 Bio Farma) in Bandung, 2005.

5 7. The antibody response and safety after National Immunization Day with trivalent Oral Polio Vaccine (t OPV Bio Farma) in Banjarbaru, Immunogenicity and Safety of DTwP (Bio Farma) Vaccine, with modified medium for pertussis cultivation, Bandung, Protectivity and safety of Td (Bio Farma) vaccine in adolescents (Bridging Study), Bandung Comparative Evaluation of Immunogenicity and Safety of monovalent Oral Polio Vaccine Type 1 (mopv1 Bio Farma) With Trivalent OPV (topv Bio Farma) in Indonesian Children, Bandung Protectivity and safety of Influenza HA Vaccine in adolescents and adults, Post Marketing Surveillance of Measles Vaccine, Post Marketing Surveillance of Td Vaccine, The safety and immunogenicity of DTP/HB/Hib vaccine in infants, phase I study, The safety of Hib vaccine in adults, phase I study. 16. Protectivity and Safety Following recombinant Hepatitis B (Bio Farma) vaccine Immunization in Healthy Adolescents, Immunogenicity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB (Bio Farma) vaccine given simultaneously with Hib (Registered) vaccine in Indonesian infants 18. The safety and tuberculine conversion of BCG vaccine (Serum Institute of India.Ltd.) Moscow strain compared to BCG vaccine (Bio Farma) Pasteur strain in infants. 19. Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Centers Trial, Evaluation on Immunogenicity & Safety Profile of topv (Bio Farma) with different batch numbers in Indonesian Infants, Antibody Persistence After Primary Doses, Immune Response and Safety After Booster Doses of Pentabio Vaccine In Indonesian Children at month of Age, 2014.

6 22. Safety Profile Following Pentabio Vaccination in Indonesian Infants, Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children, (Bridging Study), Publications & Journals: 1. Rusmil K, Fadlyana E, Bachtiar NS. Response to Hepatitis B booster in nonresponder subjects. Sari Pediatri. 2010;12(2): Fadlyana E, Rusmil K, Bachtiar NS, Gunadi R, Sukandar H. Immunogenicity and safety of a trivalent inactivated influenza vaccine. Paediatrica Indonesiana. 2011;51(1): Bachtiar NS, Masria S, Husin UA. Titer IgG Pertusis pada Usia Remaja, Dewasa, Orang Tua Menggunakan Metode ELISA dan Mikroaglutinasi Pertusis. Majalah Kedokteran Bandung. 2011;43(1): Eddy Fadlyana, Kusnandi Rusmil, Herry Garna, Iwin Sumarman, Soenarjati Soedigdo Adi, Novilia Sjafri Bachtiar. Immunogenicity and safety of diphtheria tetanus vaccine on teenagers. Ind J.Appl.Sci. 1(2):2011; U Heininger, Bachtiar NS, P Bahri,et al. The concept of vaccine failure. Vaccine (30) Jan Bonhoeffer, Babatunde Imokhuede, Grace Aldrovandi, Novilia S Bachtiar, Eng-Soon Chan, Soju Chang, et al. Template protocol for clinical trial investigating vaccines-focus on safety elements. Vaccine 31(2013); Eddy Fadlyana, Kusnandi Rusmil, Herry Garna, Iwin Sumarman, Soenarjati Soedigdo Adi, Novilia Sjafri Bachtiar. Imunogenisitas dan Keamanan vaksin Tetanus Difteri (Td) pada Remaja sebagai Salah Satu Upaya mencegah reemerging Disease di Indonesia. Sari Pediatri, 2013:15(3); Kusnandi Rusmil, Eddy Fadlyana, Novilia Sjafri Bachtiar, Hadyana. Safety and Immunogenicity of the DTP/HB/Hib combination vaccine: phase I study. Paediatr Indones;2013:53(6):

7 9. Eddy Fadlyana, Kusnandi Rusmil, Novilia Sjafri Bachtiar. Kekebalan dan keamanan setelah mendapat Imunisasi Hepatitis B rekombinan pada anak remaja. Sari Pediatri, Vol. 15, No. 2, Agustus 2013: Julitasari Sundoro, Novilia Sjafri Bachtiar, Syafriyal. Protektivitas, reaksi local dan reaksi sistemik, setelah Imunisasi dengan vaksin Td pada anak Sekolah Dasar di Indonesia. MKB, Volume 46 No. 3, September 2014: Acep T Hardiana, Ardini S Raksanagara, Rd Tina D Judistiani, Dyah Widhiastuti, Novilia S Bachtiar. Analisis Penyebaran dan Genotipe Rubela di Jawa Barat Tahun Jurnal Farmasi Klinik Indonesia, Maret 2015:4(1): Julitasari Sundoro, Novilia Sjafri Bachtiar, Syafriyal. Protektivitas, reaksi lokal dan reaksi sistemik, pascaimunisasi dengan vaksin campak (Bio Farma) dari bets vaksin yang berbeda pada anak sekolah dasar di Sumatera Barat. MKB, 2015;47(3): Rusmil K, Fadlyana E, Gunadi R, Bachtiar NS, Hadyana H. The Safety of Haemophilus influenzae type b/polyribosylribitol phosphate-tetanus (Hib/PRP-T) Vaccine, Phase I Study. IJIHS 2015;3(2): Kusnandi Rusmil, Hartono Gunardi, Eddy Fadlyana, Soedjatmiko, Meita Dhamayanti, Rini Sekartini, Hindra Irawan Satari, Nelly Amalia Risan, Dwi Prasetyo, Rodman Tarigan, Reni Garheni, Mia Milanti, Sri Rezeki Hadinegoro, Suganda Tanuwidjaja, Novilia Sjafri Bachtiar, Rini Mulia Sari. The immunonegicity safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule. BMC Pediatrics 2015;15: Ni Putu Siadi Purniti, Novilia Sjafri Bachtiar, Ida Bagus Subanada, Ayu Setyorini, Putu Junara Putera, Wayan Gustawan, IGA Trisna Windiani, Julitasari A, Syafriyal, Rini Mulia Sari. Safety and Tuberculin Conversion following BCG Moscow Strain Vaccination to Pasteur Strain in Indonesian Infants. Sari Pediatri 2015;17(3): Bonetto C, Trotta F, Alarcon GS, Santucio C, Bachtiar NS, Brauchi Pernus Y, Chandler R, Girolomoni G, Hadden RD, Kucuku M, Ozen S, Pahud B, Top K, Varrichio F, Wise RP, Zanoni G, Zickovic S, Bonhoeffer J; Brighton

8 Collaboration Vasculitis Working Group. Vasckulitis as an adverse event following immunization-systemic literature review. Vaccine 2015 Sept 21:S X. Poster: 1. Rusmil K, Fadlyana E, Gunadi R, Dhamayanti M, Boedisetianto E, Bachtiar NS. Protectivity and safety of influenza HA (Bio Farma) vaccine in adolescents and adults (Bridging Study). Proceeding of the 13th Asian Pacific Congress of Pediatrics, Shanghai, China; 2009 October Moedjito I, Hartati E, Bachtiar NS. Antibody Response in Healthy Infants Receiving either Oral Monovalent Polio vaccine Type 1 or Oral Trivalent Polio Vaccine after Primed with Trivalent OPV at Birth. The 5 th Asian Congress of Pediatric Infectious Diseases, Taiwan 2010; Moedjito I, Meriastuti I, Bachtiar NS. Immunogenicity of Trivalent Oral Polio Vaccine and Enhanced Inactivated Polio Vaccine (eipv) in Healthy Infants Primed with Neonatal topv. The 5 th Asian Congress of Pediatric Infectious Diseases, Taiwan 2010; JE Bines, C Kirkwood, J Buttery, M Danchin, R Bishop, G Barnes, E Watts, J Standish, K Leet, J Carlin, W Siero, P Jackson, A Mullock, Y Soenarto,, J At Thobari, C Dewi Satria, Bachtiar, Maharani, P Sukanto. Development of the RV3-BB vaccine: A human neonatal rotavirus vaccine aimed at the prevention disease from birth. Tenth International Rotavirus Symposium, Bangkok, Thailand, Fadlyana E, Rusmil K, Novilia Sjafri Bachtiar, Gunadi R, Sukandar H. Clinical Trial of Flubio (Bio Farma Influenza HA Trivalent) Vaccine. 5th Indonesian Influenza Foundation Symposium, Jakarta 2013:29.

9 6. Fadlyana E, Rusmil K, Novilia Sjafri Bachtiar, Gunadi R, Sukandar H. Immunogenicity and Safety of an Inactivated Influenza Vaccine. (Flubio/Bio Farma Inluenza HA Trivalent). 5th Indonesian Influenza Foundation Symposium, Jakarta 2013: Rusmil K,Fadlyana E, Maita Dhamayanti, Rachmat Gunadi, Novilia Sjafri Bachtiar. Protectivity and safety of influenza HA vaccine in adolescent and adults. 5th Indonesian Influenza Foundation Symposium, Jakarta 2013: Novilia Sjafri Bachtiar, Yani Sukriyani, Lestari, Rini Mulia Sari. Validation of hemagglutination inhibition assay for influenza antibody titer. 5th Indonesian Influenza Foundation Symposium, Jakarta 2013: Rusmil K, Bachtiar NS, Fadlyana E, Dhamayanti M, Tarigan R, Sukandar Hadyana. Immunogenicity and Safety of DTP/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants. 9th World Vaccine Congress, Sitges, Spain 2013:P Iskandar, NS Bachtiar, A Azhari. The role of academics (under the Indonesian Society of Microbiology) in the development of vaccine industry. PERMI, Seminar Nasional, Padang, 16 Oktober Soedjatmiko, Medise BE, Hadinegoro SR, Gunadi H, Sekartini R, Satari HI, Bachtiar NS, Sari RM, Puspita M, Fahmi J. Safety of Flubio (Bio Farma Influenza HA Vaccine) in 6 months-11 Years Indonesian Children. 5 th Asian Vaccine Conference (ASVAC) Hanoi Juni Kusnandi Rusmil, Hartono Gunardi, Eddy Fadlyana, Soedjatmiko, Meita Dhamayanti, Rini Sekartini, Hindra Irawan Satari, Nelly A Risan, Dwi Prasetyo, Rodman Tarigan, Reni Ghrahani, Mia Milanti, Novilia Sjafri Bachtiar, Rini Mulia Sari. The Immunogenicity, Safety, and Consistency of an Indonesian Combined DTP-HB-Hib Vaccine in Expanded Program on Immunization Schedule. 5 th Asian Vaccine Conference (ASVAC) Hanoi Juni Reviewer:

10 1. Diarrhea: Case Definition and Guidelines for Collection, Analysis, and Presentation of Immunization Safety Data. Brighton Collaboration Guillain Barré syndrome and Fisher syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety data.brighton Collaboration. Vaccine Viscerotropic disease: Case definition and guidelines for collection, analysis, and presentation of immunization safety data, Vaccine, Global Manual on Surveillance of Adverse events Following Immunization. WHO, Recommendation to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines (replacement TRS 962 annex 1), WHO, Books: 1. Program Imunisasi di Indonesia; Sejarah dan Perkembangannya. PAEI & Bio Farma. Jakarta Januari Kontroversi Imunisasi; Bunga Rampai Kedokteran Islam. Kumpulan tulisan 33 Ahli. PROKAMI (Perhimpunan Profesi KEsehatan Muslim Indonesia) Immunisation Controversies. What you really need to know. IMANI (Islamic Medical Association & Network Indonesia) & IMAM (Islamic Medical Association of Malaysia). Juli Presentation: 1. Novilia Sjafri Bachtiar. Clinical Development of New Vaccines Phase I and II Trials. BIT s 3 rd Annual World Vaccine Congress, Beijing 2011: Novilia Sjafri Bachtiar. Clinical Development of New Vaccines Phase I and II Trials; Manufacture Perspective in Developing Country. BIT s 4 th Annual World Vaccine Congress, Beijing 2012: Novilia Sjafri Bachtiar. Test methods for Evaluation of Antibody Response to Influenza Vaccine. 4th Indonesian Influenza Foundation Symposium, Bandung 2012:27 4. Novilia Sjafri Bachtiar. Vaccine and vaccination: what does the expert says? The 5th Child Health Annual Scientific Meeting of Indonesian Pediatric Society, Bandung, October 2012:61.

11 5. Novilia Sjafri Bachtiar. Vaccine Development: from laboratory to clinical trial. 8th National Congress of Indonesian Society for Clinical Microbiology (PAMKI). November Novilia Sjafri Bachtiar. Bahan, cara pembuatan dan uji klinis vaksin. Imunisasi dalam tinjauan medis dan syariat, Jakarta April Novilia Sjafri Bachtiar HPV Vaccine, Bio Farma perspective. Meeting on Appropriate Clinical Endpoint for 2nd Generation HPV Vaccine Trial, WHO, Geneva, November 19-20, Novilia Sjafri Bachtiar. Influenza vaccines for pregnant and lactating women: Clinical data requirements for product labeling, DCVMN perspective, Geneva July Novilia Sjafri Bachtiar. Vaksin. Universitas Andalas. Padang, October Novilia Sjafri Bachtiar. The Role of Bio Farma in Preventing Diseases in Indonesia and Globally. Symposium Building Vaccinology Expertise in South- East Asia, Bandung, November Novilia Sjafri Bachtiar. Aspek Penting dari Preclinical & Clinical Trial, Konsorsium Hepatitis B, Jakarta 21 Oktober Novilia Sjafri Bachtiar. The The Role of Bio Farma in Preventing Diseases in Indonesia and Globally. Advanced Vaccinology Course (NESI=Network for Education and Support in Immunization & UNPAD), Bandung 30 November Novilia Sjafri Bachtiar. Pemanfaatan Potensi Bioteknologi dalam Bidang Vaksin Sebagai Teknologi Kesehatan Masa Depan. Seminar Kesehatan Nasional, Poltelkes Kemenkes Bandung, Bandung, 1 November 2015.

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