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 40152
Office Address :PT Bio Farma
Jl.Pasteur No.28, Bandung, West Java Indonesia 40161
Phone : (+)62-22-2033755 ext 14101
Fax : (+)62-22-2037430

Educational record : 1988-1992 Medical Science, Padjadjaran University,

(UNPAD) Bandung,
1992-1994 Post Graduate Medical Education,
Padjadjaran
University (UNPAD), Bandung.
2010 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 2006 – 2012 Head of Clinical Trial Department
2002 – May 2008 Head of Measles National Laboratory
May 2004 -2006 Acting Head, Department of Clinical Trial
2001 – April 2004 Staff, Department of Clinical Trial

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Experiences :

1. WHO inter country workshop on laboratory diagnosis of measles, National

Institute of Health, Nothamburi, Thailand, August 19- 23, 2002.
2. Training on Anti-Hib ELISA (Phipps Method) 3 days, RIVM, Bilthoven, The
Netherlands, September 2-4, 2003.
3. Training on Manufacture role in GCP, The International Clinical Trial Working
Group, Aryaduta Hotel, Jakarta, 24 September 2005.
4. Ethically Good Medical Practice Combating Profesional Misconduct, University
of Indonesia, Jakarta, December 12-15, 2005.
5. Workshop on Clinical Trial Design, Monitoring and Evaluation,
International Vaccine Institute, Seoul, Korea, September 12-15, 2006.
6. Council for International Organization of Medical Sciences (CIOMS/WHO)
working group, 2007-now.
7. 7th Vaccinology Training, International Vaccine Institute, Seoul, Korea, 7-12
May 2007.
8. Training on HI test for Influenza Antibody Titre, Biken Vaccine Institute,3-14
September 2007.
9. Informal Consultation on Technical Specification for an International H5N1
Vaccine Stockpile, October 2007.
10. 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 2008.
12. Member of Indonesian Hepatitis Task Force since May 2008.
13. 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 2009 – 2012.
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 15. Joint Workshop on Environmental Monitoring Clinical Assessment, and
Variations Chiang Mai, 15-19 February 2010.
16. Consultative Committee of The WHO Global Vaccine Safety Blueprint
Project, March 2010-2012.
17. WHO informal consultation for improving influenza virus vaccine selection, 14-
16 June 2010.
18. 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 2010.
20. Global Vaccine Research Forum (GVRF) Symposia, WHO, Geneva 26-29 June
2011.
21. Global Vaccine Safety Blueprint – Global Vaccine Safety Meeting, WHO,
Geneva 26-27 September 2011.
22. Member of Indonesian Immunization Advocacy Committee, 2011-now.
23. Global Health Product Development Forum, Bill & Melinda Gate Foundation,
Seattle, May 1-3, 2012.
24. Advance Vaccinology Course (ADVAC), Annecy, May 2012.
25. Pharmacovigilance system master file tutorial. DIA, Washington, Sunday,
January 13, 2013.
26. Pharmacovigilance and Risk Management Strategies 2013, DIA,
Washington, January 14-16, 2013.
27. SAGE meeting, WHO, Geneva, November 5-7, 2013.
28. Meeting on Appropriate Clinical Endpoint for 2nd Generation HPV Vaccine
Trial, WHO, Geneva, November 19-20, 2013.
29. 9th International Symposium on Pneumococci and Pneumococcal Diseases in
Hyderabad India, March 19-13, 2014.
30. SAGE meeting, WHO, Geneva, April 1-3, 2014.
31. Global Health Product Development Forum, Bill & Melinda Gate Foundation,
Seattle, April 22-24, 2014.
32. Brighton Collaboration Working Group : Vasculitis Definition,2014 – Now.
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 33. WHO consultation meeting on influenza vaccine for pregnant and lactation
women, clinical data requirement, WHO HQ, Geneva, July 15-16, 2014.
34. The 3rd 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 29-30 November 2014.
36. Global Health Product Development Forum, Bill & Melinda Gate Foundation,
Seattle, May 5-7, 2015.
37. Continuing Professional Development & Competency in GCP, IVT GCP Training
Course, International Vaccine Institute and Widler & Schiemann AG, September
15-16, 2015.
38. The 4th meeting of Global Vaccine Safety Initiative, October 14-14, 2015, Evian,
Perancis.
39. Member of Measles Elimination & Rubella Control/CRS Verification Committee
October 2015- now.

Experience in Trials :

1. Immunogenicity and Safety of DTwP (Bio Farma) Vaccine Combined with

Recombinant Hepatitis B (GCVC) Vaccine in Indonesian Children, 2002.
2. The safety and immunogenicity of Hib (Bio Farma) vaccine in adult (Phase I),
2004.
3. 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, 2005.
4. The safety and immunogenicity of DTwP-Hepatitis B 10ug-Hib vaccine (Bio
Farma) vaccine (Phase I), 2005.
5. The Immunogenicity and safety of recombinant Hepatitis B vaccine with two
different accelerated schedules in adult, 2005.
6. The antibody response and safety after National Immunization Day with Type 1
monovalent Oral Polio Vaccine (mOPV1 Bio Farma) in Bandung, 2005.

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 7. The antibody response and safety after National Immunization Day with trivalent
Oral Polio Vaccine (t OPV Bio Farma) in Banjarbaru, 2005.
8. Immunogenicity and Safety of DTwP (Bio Farma) Vaccine, with modified
medium for pertussis cultivation, Bandung, 2006.
9. Protectivity and safety of Td (Bio Farma) vaccine in adolescents (Bridging
Study), Bandung 2007.
10. 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 2007.
11. Protectivity and safety of Influenza HA Vaccine in adolescents and adults, 2008.
12. Post Marketing Surveillance of Measles Vaccine, 2010.
13. Post Marketing Surveillance of Td Vaccine, 2010.
14. The safety and immunogenicity of DTP/HB/Hib vaccine in infants, phase I study,
2011.
15. 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, 2011-2012.
17. 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, 2012.
20. Evaluation on Immunogenicity & Safety Profile of tOPV (Bio Farma) with
different batch numbers in Indonesian Infants, 2013.
21. Antibody Persistence After Primary Doses, Immune Response and Safety After
Booster Doses of Pentabio Vaccine In Indonesian Children at 18-24 month of
Age, 2014.

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 22. Safety Profile Following Pentabio Vaccination in Indonesian Infants, 2014.
23. Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and
Children, (Bridging Study), 2014.

Publications & Journals:

1. Rusmil K, Fadlyana E, Bachtiar NS. Response to Hepatitis B booster in non-

responder subjects. Sari Pediatri. 2010;12(2):88-91.
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):22-28.
3. 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):10-15.
4. 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; 134-142.
5. U Heininger, Bachtiar NS, P Bahri,et al. The concept of vaccine failure. Vaccine
(30) 2012 1265-1268.
6. 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);5602-5620.
7. 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);141-9.
8. 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):309-14.

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 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 2013:87-92.
10. 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 2014:155-61.
11. Acep T Hardiana, Ardini S Raksanagara, Rd Tina D Judistiani, Dyah Widhiastuti,
Novilia S Bachtiar. Analisis Penyebaran dan Genotipe Rubela di Jawa Barat
Tahun 2011-2013. Jurnal Farmasi Klinik Indonesia, Maret 2015:4(1):1-7.
12. 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):155-61.

13. 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):55-9.

14. 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;15:1-10.
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):169-74.
16. 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
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 Collaboration Vasculitis Working Group. Vasckulitis as an adverse event
following immunization-Systemic literature review. Vaccine 2015 Sept
21:S0264-410X.

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 14-18.
2. 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 5th Asian Congress of
Pediatric Infectious Diseases, Taiwan 2010; 139.
3. 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 5th Asian Congress of Pediatric Infectious
Diseases, Taiwan 2010; 139.
4. 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,
2012.
5. 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.

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 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 2013:27.
7. 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 2013:25.
8. Novilia Sjafri Bachtiar, Yani Sukriyani, Lestari, Rini Mulia Sari. Validation of
hemagglutination inhibition assay for influenza antibody titer. 5th Indonesian
Influenza Foundation Symposium, Jakarta 2013:22.
9. 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:P003.
10. 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 2014.
11. 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. 5th Asian
Vaccine Conference (ASVAC) Hanoi 12-14 Juni 2015.
12. 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. 5th Asian Vaccine Conference (ASVAC) Hanoi 12-14 Juni 2015.

Reviewer:

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 1. Diarrhea: Case Definition and Guidelines for Collection, Analysis, and
Presentation of Immunization Safety Data. Brighton Collaboration.2010.
2. Guillain–Barré syndrome and Fisher syndrome: Case definitions and guidelines
for collection, analysis, and presentation of immunization safety data.Brighton
Collaboration. Vaccine 2010.
3. Viscerotropic disease: Case definition and guidelines for collection, analysis, and
presentation of immunization safety data, Vaccine, 2012.
4. Global Manual on Surveillance of Adverse events Following Immunization.
WHO, 2014.
5. Recommendation to assure the quality, safety and efficacy of recombinant human
papillomavirus virus-like particle vaccines (replacement TRS 962 annex 1),
WHO, 2015.

Books:
1. Program Imunisasi di Indonesia; Sejarah dan Perkembangannya. PAEI & Bio
Farma. Jakarta Januari 2014.
2. Kontroversi Imunisasi; Bunga Rampai Kedokteran Islam. Kumpulan tulisan 33
Ahli. PROKAMI (Perhimpunan Profesi KEsehatan Muslim Indonesia) 2014.
3. Immunisation Controversies. What you really need to know. IMANI (Islamic
Medical Association & Network Indonesia) & IMAM (Islamic Medical
Association of Malaysia). Juli 2015.

Presentation:
1. Novilia Sjafri Bachtiar. Clinical Development of New Vaccines Phase I and II
Trials. BIT’s 3rd Annual World Vaccine Congress, Beijing 2011:257.
2. Novilia Sjafri Bachtiar. Clinical Development of New Vaccines Phase I and II
Trials; Manufacture Perspective in Developing Country. BIT’s 4th Annual World
Vaccine Congress, Beijing 2012:171.
3. 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.

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 5. Novilia Sjafri Bachtiar. Vaccine Development: from laboratory to clinical trial.
8th National Congress of Indonesian Society for Clinical Microbiology (PAMKI).
November 2012.
6. Novilia Sjafri Bachtiar. Bahan, cara pembuatan dan uji klinis vaksin. Imunisasi
dalam tinjauan medis dan syariat, Jakarta April 2013.
7. Novilia Sjafri Bachtiar HPV Vaccine, Bio Farma perspective. Meeting on
Appropriate Clinical Endpoint for 2nd Generation HPV Vaccine Trial, WHO,
Geneva, November 19-20, 2013.
8. Novilia Sjafri Bachtiar. Influenza vaccines for pregnant and lactating women:
Clinical data requirements for product labeling, DCVMN perspective, Geneva
July 2014.
9. Novilia Sjafri Bachtiar. Vaksin. Universitas Andalas. Padang, October 2014.
10. 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 2014.
11. Novilia Sjafri Bachtiar. Aspek Penting dari Preclinical & Clinical Trial,
Konsorsium Hepatitis B, Jakarta 21 Oktober 2014.
12. 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
2014.
13. 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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