Clinical Research Manager
Resume:
CAREER SUMMARY:
HEALTH PROFESSIONAL, TECHNICAL ADVISOR, PROGRAM ANALYST, AND PROGRAM MANAGER with over 30 years combined experience in pharmaceutical practice, international HIV prevention and infectious diseases clinical trials, and health systems. Possess strengthening expertise, knowledge, and technical proficiency. Well developed in the areas of problem solving, communication, and organizational practices, skills, and methods, and techniques. Experienced, proven supervisor, trainer, and team builder with strong leadership abilities. Detailed experience working in a regulatory capacity supporting Institutional Review Boards (IRB). Recognized as Subject Matter Expert (SME) for Pharmacoepidemiology, with the design and execution of epidemiologic and Pharmacovigilance analyses aimed at maximizing patient safety and readiness. Experienced in planning, directing, evaluating, and coordinating epidemiological studies for public health programs. Recognized as an expert in the subject area of epidemiology. Expert ability to manage case studies, pharmaceutical projects, research programs and advise the development of public health program initiatives, policies and procedures. Ability to provide technical guidance to community health programs. Can astutely oversee and coordinate complex projects that effectively communicate organization message, philosophy and position on various issues. Effective ability to independently manage priorities. Recognized for outstanding communication skills, flexibility, keen political savvy, sense of humor and leadership abilities.
CLEARANCE: Understand SF-86; prepared to complete.
AREAS OF EXPERTISE: Pharmacoepidemiology; Pharmacovigilance Analysis; Technical Health Advisor; Public Health Programs; Infectious Disease, HIV/TB; Crisis Management; Community Outreach; Training; Program Planning, Program Management and Evaluation; Program Analysis; Consumer Safety Proficiency; Information Analysis; Women’s Health; Review Process Management; Data Quality Review; Regulations and Policies Related to Information Disclosure; Strategic Communications; Media Relations; Public Relations; Project Lifecycle Management; Public Affairs; Writing and Editing; Business Communications; Research; Social Awareness; Business Relations; Customer / Client Relations; Strategic and Operations Planning; Social Media; Critical Mention; Measures of Effectiveness; Strategic Thinking and Planning; Process Improvement and Simplification; Team and Project Leadership; Quantitative/Qualitative Analysis; Technical, Regulatory and Best Practices Research; Epidemiology; Data Analysis; Research Analyst; Lab Research; and Excellent Oral and Written Communication Skills.
TECHNICAL SKILLS: Microsoft Office Suite (Word, Excel, Outlook, PowerPoint); Technical Writing and Presenting, Method Development; and ability to conduct credible, Internet-based research.
ENDORSEMENTS:
Antonia is a recognized expert in the field of TB medicines use and safety. Antonia has strong research and scientific investigation skills: she was a principal investigator, researcher, and team leader of field studies and literature review, and author of a resulting publication Drug Use Reviews A Practical Strategy to Ensure the Rational Use of Anti-Tuberculosis Medicines (2014).
Antonia is an experienced health and pharmaceutical projects manager at both global and country levels. At the global level, Antonia represented MSH at global strategic, policy and technical meetings related to pharmacovigilance and patient safety lead by WHO, communicated with global partners, developed agendas, and facilitated workshops and symposia at the annual UNION World Conferences on Lung Health.
Antonia’s portfolio included several multi-year country projects, most important in Kenya and the Philippines. She oversaw the development of country policies and strategies related to improved use of medicines safety of patients, communicated with the donors and partner organizations, oversaw the development of country work plans and their approval by the donor and local stakeholders, and managed the implementation. The projects that Antonia managed achieved prominent results, including changes to national MDR-TB treatment guidelines in Kenya that immediately improved patient safety, and adoption of MSH-developed electronic system for active drug safety monitoring and management, PViMS, as a national system in the Philippines. The latter required strong political and negotiation skills, and cross-cultural sensitivity at the high government level.
Antonia’s success with the management of global and country health programs can be largely attributed to her skills and experience in developing comprehensive studies of health systems, options analyses for bridging scientific, knowledge, and human capacity gaps, communicating with stakeholders, meticulously monitoring progress and results, and rapidly adjusting to changing environment.
Andre Zagorski, Principal Technical Advisor Tuberculosis
Management Sciences for Health
*********@***.***
Apart from having exceptional subject matter expertise in TB and pharmacovigilance, Antonia Kwiecien is able to apply strong analytical skills and a sound systems approach to problem solving in public health. She is a highly personable and collaborative colleague who is skilled at managing complex projects and keeping a very large number of balls in the air, while at all times fully contributing to the success of the team. I would welcome the opportunity to work with Antonia again.
Ruth Lopert, MD MMedSc FAFPHM
LWC Health - Global Health and Pharmaceutical Policy Consulting
****@*********.***
Antonia is highly skilled public health professional with an excellent record on Pharmacovigilance program designing, management and institutionalization in lower and middle income countries. Her extensive knowledge, proactive approaches and leadership qualities helped National tuberculosis program in conceptualization of strategic framework; designing of policies and procedure; roll out of operational and capacity building plans; and sustain a model system on active drug safety monitoring & management (aDSM) for shorter Tuberculosis treatment regimen and novel TB drugs in the Philippines.
Her abilities to maximize the use of resources helped the project in the Philippines to operationalize the “Pharmacovigilance Information Management System” in 9 regions and at central level which was huge output in a short time and limited resources. She is very well respected in her team, counterparts and management and an asset for any organization. I wish her a great success in future.
Mehmood Anwer, Country Project Director
Management Sciences for Health
**********@*****.***
WORK EXPERIENCE:
PUBLIC HEALTH CONSULTANT
01/02/2017 – Present
Duties, Accomplishments and Related Skills:
PROVIDE TECHNICAL AND POLICY GUIDANCE IMPLEMENTING World Health Organization, Global Fund, and USAID policies, processes, and activities in support of assigned countries.
ORGANIZE AND FACILITATE WORKSHOPS. Develop and negotiate event content. Guide and manage the group event to ensure that the participant’s objectives are met effectively, with clear thinking, good participation and full buy-in from everyone who is involved. Record and disseminate decisions and outputs, and responsibility for, and commitment to, action.
DESIGN AND FACILITATE DELIVERY OF IN-PERSON AND DISTANCE LEARNING PROGRAMS, including Training of Trainers (TOT) workshops for health care providers.
EVALUATE THE TECHNICAL AND SCIENTIFIC MERIT of manuscripts and provide guidance on how the author can improve their paper.
Management Sciences for Health
4301 North Fairfax Drive, Suite400
Arlington VA, 22203 United States
05/18/2009 – 10/20/2017
SENIOR TECHNICAL ADVISOR
Duties, Accomplishments and Related Skills:
DEVELOPED, DIRECTED, AND OVERSAW GUIDANCE IN ESTABLISHING and implementing pharma-technical processes and programs to advise strategic on planning, operations, studies, and reviews. Supported, managed, and supervised day-to-day operations, including resource management processes affecting planning, management advisement, organizational guidance, pharma-technical advisement, and pharmaceutical operations.
PHARMACOLOGICAL ANALYST, TECHNICAL EXPERT, AND SENIOR ADVISOR: Adeptly applied pharmacoepidemiological and Pharmacovigilance (PhV) expertise in managing analytical drug studies, including drug safety, medical treatment, adverse events, drug management, risk mitigation, and patient safety.
Responsible for project results, technical strategic planning, maintenance of documentation, and stakeholder management.
PROGRAM DESIGN AND RESEARCH STUDY IMPLEMENTATION: Performed highly regarded analyses, analytical studies, and drug safety management studies, relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
PHARMA-REGULATORY SUPPORT, PROGRAM MANAGEMENT ADVISEMENT: Provided expert technical advisory support in conducting pharmaceutical studies for human case studies to bring treatment, therapy, medication, and a cure to diseases, sicknesses, illnesses, disorders, and conditions. Designed, defined, and updated case studies, investigations, research, and experiments.
● Led a team of colleagues and work in collaboration with partners to assist countries implement plans to introduce bedaquiline in 10 USAID priority, high burden multi-drug resistant tuberculosis countries in a timely and rational manner.
● Supported the development and implementation of PViMS a Pharmacovigilance Management System for public health programs in lower- and middle-income countries.
● Developed Drug Use Reviews A Practical Strategy to Ensure the Appropriate Use of Anti-Tuberculosis Medicines (DUR) System and contributed to the implementation of a DUR system for the National Tuberculosis, Leprosy, and Lung Disease program in Kenya.
● Provided technical assistance to implement the system and pharmacovigilance activities for HIV/TB programs in Ukraine, Bangladesh, and Swaziland.
● Contributed to the development of and ensured timely delivery of e-TB Manager (a management information system) training materials for the USAID Ukraine TB program. Ensured the timely editorial review of, and provided technical assistance for the Namibia Standard Treatment Guidelines prior to publication of the first edition.
PROVIDED DIRECT TECHNICAL ASSISTANCE TO IMPROVE INTERNATIONAL PHARMACEUTICAL systems in developing countries in support of USAID Strategic Objectives for the Systems to Improve Access to Pharmaceuticals and Services (SIAPS) Program. Provided field-based technical assistance for Tuberculosis Health Systems Strengthening activities.
RESEARCHED COMMUNICATION AND DATA ANALYSIS: Successful with operating technology and research program software to manipulate datasets, while using large databases. Skilled written and oral communication skills, clearly addressing, informing, reporting, requesting, and relaying data, information, advisement, and results to senior managers, staff, contractors, and internal and external customers within an organization.
CLINICAL RESEARCH PRACTICES: Consistently directed, advised, oversaw, reviewed, managed, reported, and evaluated complex and extensive research practices. Participated in precedent-setting research protocol studies, involving medical treatment facilities (MTF). Possess strong ability to institute and implement broad, state-of-the-art techniques and use latest approaches for improved management of the compliance review and process procedures.
ANALYZED AND ESTABLISHED MEASURABLE GUIDELINES to eliminate compliance gaps. Ensured exposure of innovative techniques to implement new approaches to improve management of protocol evaluation processes.
INTERPRETED COMPLEX DATA TO VALIDATE CONCLUSIONS AND UNDERSTAND big picture significance. Analyzed, planned, and implemented advocacy and public health strategies. Assessed and performed analyses of technical data and regulatory information.
REGULARLY PARTICIPATED IN THE RESEARCH AND DEVELOPMENT of data collection and data entry processes and study analysis, including being a key-person in the preparation of research reviews, progress reports, and analysis reviews.
SUPPORTED THE GLOBAL TB PORTFOLIO WITH A FOCUS ON RATIONAL DRUG USE, pharmaceutical regulation and product quality assurance activities. Provided technical expertise to partners and collaborators (e.g., World Health Organization, KNCV Tuberculosis Foundation, Global Drug Facility, Global Fund to Fight AIDS, Tuberculosis and Malaria).
PHARMACOVIGILANCE (PhV) PROGRAM MANAGEMENT AND ANALYSIS: Expert research analyst in the areas of drug safety, data collection, research collection and dissemination, detection, assessment, monitoring, and prevention of pharmacological adverse effects of practices and products.
PHARMACOLOGICAL PRACTICES, RESEARCH STUDIES, AND PHARMACEUTICAL SAFETY: Drug safety analyst with the ability to conduct research, review and report adverse events, analyze risk mitigation practices, and review patient safety methods, and research systems.
CONVEY STRONG DATA REVIEW, CONSENT MANAGEMENT AND STUDY PRESENTATION: Effectively reviewed data collection processes with staff, contractors, management, and review subjects. Programmatically and diplomatically worked with research subjects to review, advise, request, and obtain consent, domestically or internationally.
EVALUATED DATA COLLECTION, QUALITY CONTROL AND DATA UTILIZATION METHODS USED to study epidemiological problems and issues. Oversaw the review of potential contracts, awarded grants, and memorandums of understanding, letters of intent, and cooperative agreements, executing required monitoring and management duties for epidemiological studies.
HIGHLY EXPERIENCED WITH DESIGNING, planning and initiating epidemiologic studies, surveys and lab research investigations. Exposed to national and international study panels, including recognized as an expert in the field epidemiological issues on critical problems in the field of epidemiology.
ETHICAL COMPLIANCE AND SUBJECT REVIEWS: Proficiently versed with all required standards, guidelines, parameters, principles, and regulations to ensure compliance with ethical guidelines for scientific and human subjects research.
INTERPRETED REGULATIONS, POLICY AND PROCEDURES and recommended updates and changes to improve national tuberculosis program operations. Ensured compliance with laws and regulations. Maintained staff credentialing and addressed any compliance issues.
INFORMATION GATHERING AND ANALYSIS: Worked directly with program director to collect necessary information. Gathered and analyzed information and presented to management allowing them to make informed decisions. Gathered pertinent information through thorough review, discussion with coworkers, trend and best practices research, and conducting a survey. Analyzed data to evaluate techniques, approaches, trends and future requirements.
DEMONSTRATED EFFECTIVE INTERPERSONAL, ORAL AND WRITTEN COMMUNICATION SKILLS: Fostered collaborative working relationships and reconciled viewpoints to build consensus among multidisciplinary team members. Presented monthly reports to program director and brief management on the status of assigned projects. Provided professional assistance to co-workers and other staff on operational issues of projects.
● Leveraged strong communications and liaison skills to establish a high level of trust. Successfully mastered the political environment and became adept in discerning with whom and when to share sensitive and confidential information.
EXCELLENT WRITTEN RESEARCH SKILLS: Methodically worked with coworkers, managers, staff, and contractors to develop detailed guidance on preparing standard operating procedures (SOP), research practice processes, research proposals, manuscripts, and abstracts.
Supervisor: Andre Zagorski, Phone: 703-***-****, Okay to contact: Yes
Family Health International
1825 Connecticut Ave NW
Washington, DC 20000 USA
11/dd/2000 – 05/dd/2009
Career Progression
SENIOR CLINICAL RESEARCH MANAGER
06/dd/2006 – 05/dd/2009, SEA ICRN
11/dd/2000 – 06/dd/2006, HPTN
Duties, Accomplishments and Related Skills:
PROVIDED TECHNICAL ASSISTANCE FOR THE NIH FUNDED South East Asia Infectious Disease Clinical Research Network (SEA ICRN) on avian influenza and emerging infectious disease clinical trial related matters.
● Developed a manual to cover the entire workings of the South East Asia Infectious Disease Clinical Research Network. Became liaison with multiple internal and external partners (NIAID, Oxford, Eijkmann, FHI), and developed industry standards, systems to work across 15 clinical sites in Asia and the US.
MANAGED THE NIH SOUTH EAST ASIA INFECTIOUS DISEASE CLINICAL RESEARCH NETWORK Program in Indonesia, Thailand and Vietnam. Provided leadership to Clinical Trial Support Specialists supporting research naive field sites and study pharmacies to ensure the implementation of avian influenza research activities according to GCP and local and federal regulations. Contributed to the development and maintenance of study policies and procedures and conduct study specific trainings.
PROGRAM MANAGEMENT AND ANALYSIS: Delivered backstopping project management assistance for PATH’s Rotavirus Vaccine Program RotaTeq vaccine efficacy and safety study in Vietnam. Administered training and guidance to new Institutional Review Board members in human subjects protection.
OVERSAW THE DEVELOPMENT AND IMPLEMENTATION OF DOMESTIC AND INTERNATIONAL HIV Prevention clinical research projects in India, South Africa, Tanzania and Zambia, and the US.
● Managed the NIAID HPTN 049 and 050 Microbicide trials from protocol development through manuscript publication.
PROVIDED COMPLEX QUANTITATIVE AND QUALITATIVE ANALYSIS to measure project effectiveness and efficiency. Sought the root causes of challenges with organizational policies and processes, and worked to efficiently resolve them, while serving as serving as project leader in planning and coordinating efforts of key officials of federal, state and national organizations.
GATHERED AND ANALYZED INFORMATION: Analyzed information collected from a wide variety of sources to determine nature and scope of issues, interpret materials and develop policy options and organization approaches for consideration. Compiled survey data and developed final determination and evaluation to assess international health problems.
SUBJECT PARTICIPATION AGREEMENT, CONSENT ADVISEMENT, AND VOLUNTEER PARTICIPANTS: Used skilled communication abilities to advise proper patient-care needs, ensure volunteer agreements in proper format. Requested legal advisement of all aspects of subject agreements, consents, and participants.
MANAGED, PLANNED, DESIGNED, REVIEWED, SCHEDULED, AND IMPLEMENTED strategic, clinical research activities of multiple studies. Actively recruited and selected eligible participants for research studies. Reviewed, considered, changed, and edited subject volunteer agreements to ensure appropriate legal components, and ensuring volunteer agreements including legalese. Developed procedural language that is logical, appropriate, and relevant to education level for subjects.
HIGHLY SKILLED EXPERIENCED RESEARCHER: approved research protocols in healthcare settings; experience working in conjunction with research oversight boards, entities, and panels. Effectively worked with research teams, subjects, and investigators to monitor human subjects research protocol compliance.
INTERFACED WITH RESEARCH TEAMS TO SUPPORT THE EFFICIENT FUNCTIONING of research protocols. Skilled at managing clinical research protocols, analyzing, reviewing, and evaluating human research protocols.
INITIATED, COORDINATED, AND ADVISED CLINICAL RESEARCH ACTIVITIES and presented research, reports, case studies, and clinical trial reports. Conducted operational research methodology, statistics, and human subjects protections and certification in the clinical areas of research compliance, program analysis, program management, and scientific research.
PROBLEM SOLVING AND RESOLUTION: Provided excellent problem solving skills to clarify patient medication and treatment. Analyzed organizational and operational problems and developed solutions. Managed and advised on operations, analysis and resolution of logistics problems, operational problems and programmatic opportunities.
PROVIDED EXCELLENT CUSTOMER SERVICE through analysis of customer feedback and focus of attention on areas requiring improvement. Developed and maintained positive relationships with clients, employees and vendors. Identified and fulfilled client needs with products and services within sphere of influence. Recognized by management and clients for exceptional customer service practices.
COMMUNICATED ORALLY AND IN WRITING: Effectively communicated with physicians in regards to patient treatment and clarified and any other questions and concerns. Explained procedures and observed patients to ensure safety and comfort during study procedures. Educated, advised, negotiated, collaborated and built support for ideas and initiatives, tactfully and diplomatically addressing issues in contention or sensitive.
DEMONSTRATED EFFECTIVE ORAL AND WRITTEN COMMUNICATION SKILLS by using research and analysis to develop and prepare briefs, white papers, reports and presentations for senior level management. Prepared and delivered presentations to dignitaries and senior officials, effectively communicating the success and challenges of the organization.
Supervisor: Janet Robinson, Phone: +66-2-263-2300, Okay to contact: Yes
Quintiles BRI
4820 Emperor Blvd, Durham, NC 27703
Durham, NC,27703 United States
02/dd/1998 – 06/dd/2000
MANAGER, CLINICAL DATA MANAGEMENT / SENIOR DRUG SAFETY ASSOCIATE
Duties, Accomplishments and Related Skills:
OFFERED TECHNICAL EXPERTISE TO ORGANIZATION FOR SPECIFIC PROJECTS involving clinical coding, using MedDRA, WHO, ICD-9, HARTS, COSTART, and client-specific dictionaries. Contributed and participated in developing marketing of Quintiles services, including supervised two clinical coders and two programmers.
MONITORED SERIOUS ADVERSE DRUG EXPERIENCES, WHILE CONDUCTING clinical trials. Assisted in the preparation of protocols, CRF pages, study conduct issues and final reports. Assured accurate and consistent clinical coding for data management. Represented the department and Quintiles BRI at client meetings and participated in investigator meetings.
IMPLEMENTED AND MANAGED NEW CLINICAL CODING GROUP for the Clinical Data Management department. Regularly assisted, advised, and supported clinicians, research staff, contracting staff, and senior research analyst through performing and directing teams. Reviewed and became subject matter expert (SME) of drug safety, pharmacological practices, patient safety and medical treatment reactions, and medical research systems.
PROBLEM SOLVING AND RESOLUTION: Provided excellent problem solving skills to clarify patient medication and treatment. Analyzed organizational and operational problems and developed solutions. Managed and advised on operations, analysis and resolution of logistics problems, operational problems and programmatic opportunities.
PROVIDED EXCELLENT CUSTOMER SERVICE through analysis of customer feedback and focus of attention on areas requiring improvement. Developed and maintained positive relationships with clients, employees and vendors. Identified and fulfilled client needs with products and services within sphere of influence. Recognized by management and clients for exceptional customer service practices.
EFFECTIVE COMMUNICATOR: Possessed strong, effective communication skills that are required in environments that are ever-changing and demanding. Well-versed in communicating information, responsibilities, tasks, projects, assignments, and expectations. Consistently strive to create an improving learning environment to move forward with goals and objectives.
Supervisor: Jane Diefenbach, Phone: 510-***-****, Okay to contact: Contact me first
Innovex (a division of Quintiles)
151-161 Boulevard Victor Hugo,
93400 Saint-Ouen, France
04/dd/1996 – 02/dd/1998
CLINICAL TEAM LEADER / SENIOR CLINICAL RESEARCH ASSOCIATE
Duties, Accomplishments and Related Skills:
ASSISTED PROJECT MANAGER WITH PLANNING AND ADMINISTERING clinical projects. Supervised two teams of Clinical Research Associates, eight in-house and four field-based. Conducted all aspects of clinical trial monitoring.
PROJECT TEAM LEADER FOR A TEAM OF EIGHT Clinical Research Associates. Oversaw technical support staff performing task work associated with assigned projects. Managed clinical, regulatory and data management assignments completed by the project manager. Served as mentor and translator for projects, and trained new team members on study-related responsibilities.
HIGHLY TRAINED IN USING SPECIALIZED SKILLS TO APPLY pharmacoepidemiological and pharmacovigilance (PhV) knowledge, skills, and expertise in the researching, planning, designing, redesigning, effective implementation, and research analysis of multiple-major analytical studies, involving drug safety, review and reporting adverse events. Understood and applied risk mitigation practices, and effectively communicating patient safety health outcomes.
ORAL AND WRITTEN COMMUNICATION SKILLS: Skillful communicator with the ability to write, edit, and present information in concise, brief, reports. Created clear, daily, weekly, and monthly status reports for management review. Familiar with the processes of identifying areas of agreement to find common grounds for cooperative business relationships.
Supervisor: Peter Payne, Phone: 919-***-****, Okay to contact: Contact me first
EDUCATION:
University of Alberta, Faculty of Pharmacy, Edmonton, Alberta, Canada
Degree: Bachelor of Science, Major: Pharmacy
LANGUAGES:
Proficient in French
PUBLICATIONS:
● WHO Treatment guidelines for drug-resistant tuberculosis – 2016 update. May, 2016, WHO/HTM/TB/2016.04
● World Health Organization. Active tuberculosis drug-safety monitoring and management (aDSM) Framework for implementation, November 2015, WHO/HTM/TB/2015.28
● Drug Use Reviews A Practical Strategy to Ensure the Rational Use of Anti-Tuberculosis Medicines - SIAPS. 2014. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
● Reem Ghoneim, Laurie Hall, Antonia Kwiecien, and David Lee - Technical Assistance And Support, Namibia Standard Treatment Guidelines ©, 2011 Ministry of Health and Social Services, Directorate: Tertiary Health Care and Clinical Support Services, Division: Pharmaceutical Services
● Shretta, R. and A. Kwiecien. 2010. Intermittent Preventive Treatment with Sulfadoxine-Pyrimethamine in Burundi. Submitted to the U.S. Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health.
● Muzala Kapina, MBCHB; Cheri Reid, RN, MPH; Karisse Roman, MPH; Elena Cyrus-Cameron, MPH; Antonia Kwiecien, BSc; Stephen Weiss, PHD; Sten H. Vermund, MD, PHD. HIV Incidence Rates and Risk Factors for Urban Women in Zambia: Preparing for a Microbicide Clinical Trial. Sexually Transmitted Diseases. 36(3):129-133, March 2009.
● Wafaa M. El-Sadr, Kenneth H. Mayer, Lisa Maslankowski, Craig Hoesley, Jessica Justman, Fang Gai, Christine Mauck, Judith Absalon, Kathleen Morrow, Benoît Mâsse, Lydia Soto-Torres and Antonia Kwiecien for the HIV Prevention Trials Network (HPTN) 049 Protocol Team. Safety and Acceptability of Cellulose Sulfate as a Vaginal Microbicide in HIV-infected Women. AIDS. 20(8):1109-1116, May 12, 2006.
● Kenneth H. Mayer, Lisa A. Maslankowski, Fang Gai, Wafaa M. El-Sadr, Jessica Justman, Antonia Kwiecien, Benoît Mâsse, Susan H. Eshleman, Craig Hendrix, Kathleen Morrow, James F. Rooney, Lydia Soto-Torres and the HPTN 050 Protocol Team. Safety and Tolerability of Tenofovir Vaginal Gel in Abstinent and Sexually Active HIV-Infected and Uninfected Women. AIDS. 20(4):543-551, February 28, 2006.
AFFILIATIONS:
Expert Advisory Group Member:
● WHO Global TB Programme’s Consolidated Guidelines for the Treatment of Tuberculosis
● WHO Global TB Programme’s Active Drug-Safety Monitoring and Management (aDSM)
ADDITIONAL INFORMATION:
Union World Conference on Lung Health Symposia and Workshop Presentations
2015 Cape Town South Africa - A New Agenda: Lung Health beyond 2015
Symposium Presentation
● Strengthening pharmacovigilance systems: improving TB patient safety and reducing the adverse drug reaction burden
Workshop Presentations
● Ensuring MDR-TB patient information and adherence counselling is a key part of patient-centered care
● Strengthening medication counselling and adherence support for DR-TB patients
● Safety of anti-TB drugs
2014 Barcelona, Spain - Community-driven solutions for the next generation
Symposium presentations
● Community-driven psychosocial support: don't forget medication counselling!
● Multiple dimensions of counselling and options for prioritization and intervention
● Improving patient treatment outcomes for tuberculosis using a risk minimization approach
2013 Paris, France - Shared air, safe air?
Symposium presentation
● MDR-TB Drug Utilization Review Programs: Tool to ensure rational use of second-line anti-tuberculosis drugs
2012, Kuala Lumpur, Malaysia
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