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  1. Women's Health Research

OWH Presentations and Publications

Through presentations, peer-reviewed publications, and book chapters, OWH staff and OWH-funded researchers are working to advance the science of sex differences and foster a greater understanding of FDA’s policies and initiatives in this area. Check one of the publications or presentations highlighted on this page to learn more about these efforts.

Publications

Presentations

October 2018

  • Plenary: "Cardiovascular, Renal and Metabolic Diseases: Gender-Specific Implications for Physiology”, 2018 American Physiological Society Conference, Oct. 3, Knoxville, TN.

July 2018

  • Panel Presentation: Intro to OWH/sex and gender drug development pipeline. 2018 AACP Annual Meeting Scientific Session, July 23,.Boston, MA.

June 2018

  • Panel Introduction: Government Stakeholders Panel. Women, Heart and Brain Global Initiative Stakeholders Meeting, June 11, Cambridge, MA.

May 2018

  • Plenary: “FDA Women’s Health: Advances Opportunities & Challenges”. Marjorie Jenkins. 2018 28th Annual Women’s Health Congress. Sunday, May 6, Arlington, VA.
  • Panel Introduction: “Including Pregnant Women and Lactating Women Clinical Trials: Controversies, Challenges & Opportunities”. Marjorie Jenkins. 2018 Society for Clinical Trials Conference (SCT), May 22, 2018, Portland, OR.

April 2018

  • Clinical Seminar: “Advances in Women’s Health: An Overview on Inclusion in Clinical Trials and Minimizing Research Gaps in Pregnant and Lactating Women”. Marjorie Jenkins. 2018 ACOG Annual Clinical and Scientific Meeting, April 29, 2018, Austin, TX.
  • Moderator, Panel Introduction: The future of research in sex and gender differences- implications of in silico models in women’s health. OSSD. Marjorie Jenkins, April 30-May 3, Atlanta, GA.

February 2018

  • Presentation: Supporting Cutting-Edge Omics Research to Advance Sex and Gender-Specific Women’s Health in Cardiovascular Diseases. Michelle T. Luo. 2nd International Conferences on Genomic Medicine (GeneMed-2018), February 26-28, 2018, Houston, TX.

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December 2017

  • Panel Presentation: Opioid Epidemic: Sex and Gender Influences. Marjorie Jenkins. NIH Office of Research on Women's Health (ORWH) Women's Health Seminar Series: "Sex and Pain: What's the Story?", December 7, 2017, Bethesda, MD.

November 2017

  • Oral Presentation: The Impact of Health Policy on Patient Outcomes: Considerations of Sex Differences. Marjorie Jenkins. California American College of Cardiology Meeting, November 17, 2017, Beverly Hills, CA.

October 2017

  • Oral Presentation: Counseling Patients on Medication Use During Pregnancy: Why You Need to Be Talking About Pregnancy Exposure Registries. Robin D. Johnson. 20th Annual NPWH in Women’s Health Premier Women’s Health Care Conference, October 13, 2017, Seattle, WA.
  • Oral Presentation: Diverse Women in Clinical Trials: The Role of FDA Office of Women's Health. Marjorie Jenkins. Research Centers in Minority Institutions (RCMI) Translational Science Conference, October 30, 2017, Washington, DC.

September 2017

  • Oral Presentation: Epidemiology of the Opioid Epidemic: A focus on sex differences. Pamela Scott. FDA Seminar: Opioids: FDA Initiatives and Exploring Sex as a Biologic Variable. September 27, 2017, Silver Spring, MD.
  • Oral Presentation: Partnering for Healthy Pregnancies–FDA Pregnancy Resources. Robin D. Johnson. DHHS/OASH, HRSA/MCHB, & FDA/OWH Webinar: Partnering for Healthy Pregnancies – Before, During and After, September 28, 2017.
  • Oral Presentation: Diverse Women in Clinical Trials. Robin D. Johnson. FDA Patient Representative Program Webinar, September 28, 2017.

August 2017

  • Oral Presentation: Diverse Women in Clinical Trials: The Role of Nurses in Recruitment and Retention. Kimberly A. Thomas. National Black Nurses Association Conference. August 3, 2017, Las Vegas, NV.

July 2017

  • Oral Presentation: Strategies to Engage Diverse Patients in Clinical Trials. C. Nunez, J. Spinner, K. Thomas. National Association of Hispanic Nurses. July 19, 2017, Phoenix, AZ.
  • Panel Presentation: Progress in Including Women in Clinical Trials for FDA-Approved Products. Pamela Scott. National Medical Association's 2017 Annual Convention and Scientific Assembly. July 31, 2017, Philadelphia, PA.

June 2017

  • Poster presentation: Progress in Including Women in Clinical Trials for FDA-Approved Drugs and Biologics. Elahi M, Kallgren D, Scott P. FDA Science Forum. June 1, 2017. Silver Spring, MD.
  • Poster presentation: FDA Office of Women’s Health: Funding Innovative Omics Research to Advance Sex and Gender-Specific Women’s Health. Luo M, Elahi M, Kallgren D, Jenkins M. FDA Science Forum. June 1, 2017. Silver Spring, MD.

May 2017

  • Conference Workshop: Adaptive Clinical Trial Designs: Opportunities to Identify Sex- and Gender- Specific Outcomes. Organization for the Study of Sex Differences (OSSD). May 16, 2017, Montreal, Canada.

April 2017

  • Pre-Conference Symposium: Working Together to Address Women's Health in Research and Drug Development: Challenges and Opportunities. Pamela Scott. 25th Anniversary Congress on Women's Health. April 27, 2017, Washington, DC.
  • Oral Presentation: Progress in Including Women in Clinical Trials for FDA-Approved Products. Pamela Scott. 25th Congress on Women's Health. April 27, 2017, Washington, DC.
  • Poster Presentation: Demographics of Study Participants in Clinical Trials for Oncology Drugs Approved by FDA CDER from January to November 10, 2016. Duggal N, Geh , Soon G  et al. 25th Anniversary Congress on Women's Health. April 28 - 30, 2017, Washington, DC.

March 2017

  • Oral Presentation:  Strategies for Engaging, Recruiting and Retaining Diverse Women in Medical Research. Marjorie Jenkins. Society of Behavioral Medicine. March 31, 2017, San Diego, CA.

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November 2016

  • Poster Presentation: Clinical Trial Demographics for New Molecular Entity Drugs and Biologics Approved by FDA CDER in 2015. Wright H, Elahi M, Igun A et al. American Association Pharmaceutical Scientists (AAPS) Annual Meeting. November 13-17, 2016, Colorado Convention Center, Denver, CO.
  • Oral Presentation: Diversity in Clinical Trials: How Churches Can Play a Role. Marsha Henderson. Health Churches 2020. November 18, 2016, Charlotte, NC.

October 2016

  • Oral Presentation: Mammography Health Promotion & Women Living with a Disability, Pink Ribbon Sunday: Mammography Awareness Program. Kimberly Thomas. October 19, 2016.
  • Poster Presentation: Using Regulatory Science Informatics to Derive Insights into Demographic Subgroup Participation in Clinical Trials. Njimoluh KL, Chen A, Feng J, et al. ICBI's Biomed Inform Symposium. October 14, 2016, Georgetown University,  DC.
  • Oral Presentation: Diverse Women in Clinical Trials. Marsha Henderson. SCRS 2016 Site Solutions Summit. October 13-16, 2016, Boca Raton, FL.

April 2016

  • Panel Presentation: Diabetes Sisters Health Forum. Zakiya Bell. April 7, 2016, Silver Spring, MD.
  • Poster Presentation: Demographics of Clinical Trial Participants for New Molecular Entity (NME) Oncology Drugs and Biologics Approved by FDA CDER in 2015. Hilary Wright, Merina Elahi, Ayomide Igun et al. American Association for Cancer Research (AACR) Annual Meeting 2016, April 16-20, 2016, New Orleans, Louisiana.
  • Poster Presentation: Encouraging Diverse Women to Participate in Clinical Trials: Attitudes, Motivators and Opportunities for Engagement. Carley Thompson. Women’s Health Congress, April 14-17, 2016, Washington, DC.
  • Oral Presentation: Inclusion and Analysis of Sex and Gender Differences in Clinical Trials Supporting Approval and Clearance of FDA-Regulated Medical Products. Pamela E. Scott. International Congress on Gender and Life Style: From Puberty to Elderly Frailty. April 16, 2016, Matera, Italy.
  • Poster Presentation: Demographics of Study Participants in Clinical Trials for Oncology Drugs Approved by FDA CDER from January to November 10, 2015. Hilary Wright, Merina Elahi, Ayomide Igun et al. Women’s Health 2016, The 24th Annual Congress, April 14-17, 2016, Washington DC. 

February 2016

  • Poster Presentation:  Demographics Of Study Participants In Clinical Trials For Cardiovascular Drugs Approved By FDA CDER From January To September 2015. Hilary Wright, Merina Elahi, Ayomide Igun, et al. at: CRT 2016, February 20-23, 2016, Washington DC.
  • Oral Presentation: Update on Sex and Gender-Specific Women's Health. Marjorie Jenkins. NIH Office of Sex and Gender Minority Research, February 22, 2016, Bethesda, MD
  • Oral Presentation: Sex, Gender and Diversity in Clinical Trials. Marjorie Jenkins. Texas Heart Institute Cardiovascular Grand Rounds, February 5, 2016, Houston, TX. 

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November 2015

  • Presentation: Opening Remarks. Pamela Scott. Drug Interactions with Hormonal Contraceptives Public Meeting, November 9, 2015, Silver Spring, MD.
  • Poster: Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved at FDA CDER from 2013 to 2014. Itana H, Elahi M, Igun A, Soon G, Chen A , Pariser A, Fadiran EO. American Heart Association Scientific Conference, November 7-11, 2015, Orlando, FL. Abstract: Circulation 2015;132:A1144.

October 2015

  • Presentation: FDA's Role in Addressing Sex and Gender in Research and Education. Pamela Scott, Marjorie Jenkins. XX XY - Sex  and Gender in Medical Education Summit Mayo Clinic, October 18-19, 2015, Rochester, MN.

September 2015

  • Presentation: FDA Women's Health FY 2016 Scientific Research Goals and Objectives. Emmanuel Fadiran. NCTR Women's Health Research Day, September 1, 2015, Jefferson, AR.
  • Presentation: Development of Women's Health Research Roadmap. Pamela Scott. NCTR Women's Health Research Day, September 1, 2015, Jefferson, AR.
  • Oral Presentation: Sex Differences in Drug-induced QT Prolongation and Torsades de Pointes. Pamela E. Scott. Sex, Gender and Drugs Symposium IV: Special Focus on Arrhythmias, September 18, 2015, Karolinska Institutet, Stockholm, Sweden.
  • Presentation: Overview of OQ-prolonging drugs. Pamela Scott. Sex, Gender, and Drugs: Special focus on QT-prolonging Drugs Symposium, September 18, 2015, Karolinska Institutet, Stockholm, Sweden. 
  • Oral Presentation: Women’s Health Research and Education: An Update. Marjorie Jenkins. Sex, Gender and Drugs Symposium IV, September 18, 2015, Karolinska Institutet, Stockholm, Sweden. 
  • Oral Presentation: Addressing Sex Differences in FDA-Regulated Drugs. Pamela E. Scott. 7th Annual Meeting of the International Society of Gender Medicine, September 21, 2015, Berlin, Germany.
  • Poster Presentation: Inclusion of Women and Sex Analyses in Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by FDA from 2013 to 2014. Itana H, Elahi M, Soon G, et al. 2015 Annual Meeting of the American College of Clinical Pharmacology, September 27-29, 2015, San Francisco, CA. Abstract: Clinical Pharmacology in Drug Development 2015;4(S1):42-43 (Poster #075).

May 2015

  • Poster: Using Digital Media and Outreach Strategies to Target College-Aged Women. Zakiya Bell. American College Health Association, May 26-30, 2015, Orlando, FL.
  • Poster: Demographics by Sex and Race of Study Participants in Clinical Trials for Oncology Products Approved by FDA in 2013. Itana H, Chen A, Soon G, et al. FDA Science Forum, May 27-28, 2015, Silver Spring, MD.
  • Poster: Sex Subgroup Analyses in Pivotal Clinical Trials of New Drug and Biologic Products Approved by FDA Center for Drug Evaluation and Research in 2014. Chen A, Itana H, Xia G, et al. FDA Science Forum, May 27-28, 2015, Silver Spring, MD.
  • Poster: Sex Subgroup Analysis from US and International Sites for Pivotal Clinical Trials of New Drugs and Biologic Products Approved by FDA in January - July 2014. Xia G, Chen A, Itana H, et al. FDA Science Forum, May 27-28, 2015, Silver Spring, MD.

April 2015

  • Poster: Demographics by Sex and Race of Study Participants in Clinical Trials for Oncology Products Approved by the FDA in 2013. Itana H, Chen A, Soon G, Pariser A, Fadiran EO. Women’s Health Congress, April 2015, Washington D.C.
  • Poster: Sex Subgroup Study from US and International Sites for Pivotal Clinical Trials of New Drugs and Biologic Products Approved by CDER/FDA in January – July 2014. Xia Guanjun, Chen A, Itana H, Lu Y, Pepe S, Pariser A. Women’s Health Congress, April 2015, Washington D.C.
  • Poster: Sex Subgroup Analyses in Pivotal Clinical Trials of New Drug and Biologic Products Approved by FDA/CDER in 2014. Chen A, Itana H, Lu Y, Xia Guanjun, Pepe S, Pariser A. Women’s Health Congress, April 2015, Washington D.C.

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November 2014

  • Presentation: FDA’s Role in Women’s Health Research. Pamela E. Scott. National Institutes of Health Office of Research on Women’s Health (ORWH) Interdisciplinary Women’s Health Research Symposium, November 6, 2014, Bethesda, MD.

September 2014

  • Poster: Regulatory Impact of FDA-Office of Women’s Health Research and Development Program. Elahi M, Itana H, Barr H, Leake C, Audain G, Scott P, Fadiran E. FDA CDER Science Day, September 10, 2014, Silver Spring, MD.

August 2014

  • Panel Workshop: Using Digital Strategies to Reach Pregnant Women with Health and Safety Messages. Alison Lemon, Kimberly Thomas. National Conference on Health Communication, Marketing, & Media, August 19, 2014, Atlanta, GA.  

June 2014

  • Presentation: Diversity in Clinical Trials: FDA's Perspective. Marsha Henderson. Morehouse School of Medicine, June 19, 2014, Atlanta, GA.

May 2014

  • Presentation: Overview on Sex and Gender Considerations in Biomedical Research. Pamela E. Scott. 7th Annual Johns Hopkins University Women’s Health Research Symposium, May 21, 2014, Baltimore, MD.
  • Panel Presentation: Study Approaches and Methods to Evaluate the Safety of Drugs and Biologic Products during Pregnancy in the Post-Approval Setting; Moderator for Topic 2: Enrollment, retention, communication. Pamela Scott. May 28-29, 2014, Silver Spring, MD.
  • Oral Presentation: Using Digital Outreach and Innovative Partnerships to Raise Awareness about Pregnancy Exposure Registries. Kimberly A. Thomas. FDA Public Meeting: Study Approaches & Methods to Evaluate the Safety of Drugs & Biological Products during Pregnancy in the Post-Approval Setting. May 28, 2014, Silver Spring, MD.

April 2014

  • Presentation: Addressing Sex Differences in Biomedical Research: Drugs. Pamela Scott. The Women's Health Congress 2014: The 22nd Annual Congress, Pre-Conference Workshop, April 3, 2014, Washington, DC.
  • Poster Presentation: 20 Years of the Office of Women's Health: Health Impacts for Women from OWH-funded Research. Elahi M, Bambata N, Eshera N, et al. The Women's Health Congress 2014: The 22nd Annual Congress, April 4-6, 2014, Washington, DC. Abstract: Journal of Women's Health 2014; 23(4):42 (P121).
  • Presentation: Addressing Sex Differences in Biomedical Research: Drugs & Devices. Pamela Scott. Yale University School of Medicine - Seminar Series for SCOR and BIRCWH, April 10, 2014, New Haven, Connecticut.  
  • Presentation: Addressing Sex Differences in FDA-Regulated Products: Drugs. Pamela E. Scott. Annual Meeting of the Organization for the Study of Sex Differences, April 24-26, 2014, Minneapolis, MN.
  • Oral Presentation: Opening Remarks. Emmanuel Fadiran. Symposium III: Sex Differences in Drug and Device Development at the 8th Annual Meeting of the Organization for the Study of Sex Differences (OSSD), April 24-26, 2014, Minneapolis, MN.

March 2014

  • Presentation: Sex and Gender Considerations in Biomedical Research: Drugs & Devices. Pamela E. Scott. Women’s Health 2013, The 21st Annual Congress, Pre-Conference Workshop, March 21, 2013, Washington DC.
  • Poster: Inclusion of Women and Sex Analyses in Pivotal Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by FDA from 2010 to 2011, Eshera N, Marsh A, Chinn L, Zhang L, Fadiran E. Women’s Health 2013: The 21st Annual Congress, March 22 – 24, 2013 in Washington, DC.
  • Presentation: Office of Women’s Health Overview. Marsha Henderson. National Council of Women’s Organizations. March 18, 2014, Washington, DC.

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November 2013

  • Poster: Using plain language publications and videos to educate women about safe medication use. Thomas K. Association of University Centers on Disabilities Conference, November 18-19, 2014. Washington, DC.

October 2013

  • Poster: Demographics of Study Participants in Clinical Trails for Diabetes Drugs Approved by FDA From 2010 to 2013. Eshera N, Bambata N, Elahi M, et al. 6th Disparities Partnership Forum: Diabetes Care in High Risk Populations. A Rising Threat - The Impact of Social Determinants", October 21-22, 2013, Arlington, VA.

April 2013

  • Poster: Inclusion of Women and Sex-based Analyses in Pivotal Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by FDA from 2010 to 2012, Eshera N, Chinn L, Soon G, Fadiran E, Organization for the Study of Sex Differences (OSSD) Annual Meeting, April 25-27 2013, Weehawken, NJ.

March 2013

  • Presentation: Sex and Gender Considerations in Biomedical Research: Drugs & Devices. Pamela E. Scott. Women’s Health 2013, The 21st Annual Congress, Per-Conference Workshop, March 21, 2013, Washington DC.
  • Poster: Inclusion of Women and Sex Analyses in Pivotal Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by FDA from 2010 to 2011, Eshera N, Marsh A, Chinn L, Zhang L, Fadiran E. Women’s Health 2013: The 21st Annual Congress, March 22 – 24, 2013 in Washington, DC.

February 2013

  • Poster: Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved by FDA from 2010 to 2011, Eshera N, Marsh A, Chinn L, Zhang L, Fadiran E. Cardiovascular Research Technologies (CRT) 2013, February 23 - 26, 2013 in Washington DC.

January 2013

  • Presentation: Using Novelas to Engage Hispanic Consumers on Important Health Topics. Alison Lemon. Reaching Latinos Online Meetup. January 31, 2013.

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December 2012

  • Poster: Critical Information for Pregnant Women Taking Prescription Drugs: The FDA Pregnancy Exposure Registry Website. Beverly Gallauresi. National Rural Health Association’s 18th Annual Rural Multiracial & Multicultural Health Conference, December 4-6, 2012, Asheville, North Carolina.
  • Poster: Use of Video Nolvelas as an Outreach Tool On Safe Medication Use To Latino Women. Deborah Kallgren. National Rural Health Association’s 18th Annual Rural Multiracial & Multicultural Health Conference, December 4-6, 2012, Asheville, North Carolina.

November 2012

  • Presentation:Hispanic Marketing 3.0: How to Reach and Engage the Social and Mobile Hispanic Consumer. Alison Lemon. Digital Capital Week, November 2-9, 2012. Washington, DC.
  • Presentation: FDA Office of Women’s Health Pregnancy Exposure Registry Website. Beverly Gallauresi. American Psychiatric Nurses Association, Pittsburg, PA, November 7 - 10, 2012.

October 2012

  • Poster: Assessment of Pregnancy Labeling Across the Top 20 Therapeutic Classes by Pharmaceutical Sales (2010). O Otugo, J Choi, O Ogundare, C Vaughan, E Fadiran, L Sahin. AAPS Annual Meeting and Exposition, October 14-18, 2012 in Chicago, IL.

July 2012

  • Presentation: Using Novelas to Promote Safe Medicine Use in Women. Alison Lemon. National Association of Hispanic Nurses (NAHN), 37th Annual Conference. July 17-20, 2012. San Juan, Puerto Rico.

June 2012

  • Poster: Representation of Females and Racial/Ethnic Subgroups in FDA Approved Orthopedic Medical Devices: A Ten Year Review. D Dave, B Gallauresi. Organization for the Study of Sex Differences (OSSD) annual meeting, June 7-9, 2012, Baltimore, MD.
  • Poster: Assessment of the Consistency of Pregnancy Labeling Across Therapeutic Classes. O Otugo, J Chou, O Ogundare, C Vaughan, E Fadiran, L Sahin. Organization for the Study of Sex Differences (OSSD) annual meeting, June 7-9, 2012, Baltimore, MD.

May 2012

  • Poster: Consistency of Pregnancy Labeling Across Therapeutic Class for the Top 20 Drugs (2010) by Sales. O Otugo, E Fadiran, L Sahin. American College of Obstetricians and Gynecologists (ACOG) Clinical Meeting, May 5-9, 2012, San Diego, CA.
  • Poster: An FDA ten year review of clinical trials for approved Obstetrics and Gynecological medical devices. D Davé, J Brown, B Gallauresi. (ACOG) Clinical Meeting, May 5-9, 2012, San Diego, CA.

April 2012

  • Poster: ¡Nunca Más! Novela Series: Teaching Hispanic Women about Safe Medication Use. Kimberly Thomas. National Hispanic Medical Association Annual Conference. April 27-28, 2012.

March 2012

  • Poster: An FDA ten year review of clinical trails for approved medical devices for women. D Dave, J Brown, B Gallauresi. Women’s Health 2012: The 20th Annual Congress. March 16-18, 2012, Washington, DC.
  • Poster: Consistency of Pregnancy Labeling Across Different Therapeutic Classes. O Otugo, O Ogundare, C Vaughan, E Fadiran, L Sahin. Women’s Health 2012: The 20th Annual Congress. March 16-18 2012, Washington, DC.
  • Poster: Survey of the Presentation of Sex Analysis in the FDA Review of Efficacy and Safety Clinical Data of New Molecular Entity Drugs and Biologics Approved from 2007-2009. O Otugo, R Poon, V Copeland, K Khanijow, S Umarjee, L Chinn, E Fadiran, L Zhang, A Parekh. American Society Clinical Pharmacology Therapeutics (ASCPT) Annual Meeting. March 14-17, 2012, National Harbor, MD.
  • Poster: Comparison of Inclusion of Women in Early versus Late Phase Clinical Trials in Recently US FDA-Approved New Drug and Biologics Applications. Chinn, LW, Poon, R, Fadiran, E. American Society Clinical Pharmacology Therapeutics (ASCPT) Annual Meeting. March 12-17, 2012, National Harbor, MD.
  • Panel: Women’s Clinical Leadership Forum. Marsha Henderson. 21st Annual Partnerships in Clinical Trials Conference. March 4, 2012. Orlando, FL.

February 2012

  • Panel: Health Forum: "Making Health Care Work for Our Communities". Marsha Henderson. Delta Days in the Nation’s Capital. February 6, 2012, Washington, DC

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November 2011

  • Presentation: Pregnancy Exposure Registry website. Beverly Gallauersi. 2011 Illinois Women’s Health Conference, November 2-3, 2011, Springfield, IL
  • Presentation: Pregnancy Exposure Registry website. Beverly Gallauersi. 2011 Annual Meeting of the Association of Military Surgeons United States, (AMSUS), November 7-9, 2011, San Antonio, TX
  • Presentation: Reaching Out for Health Through Social Media. Alison Lemon. 2011 Latism National Conference, November 9-11, 2011, Chicago, IL

October 2011

  • Poster: Using video novellas and plain language publications to educate Latino women about safe medication use. Deborah Kallgren and Kimberly A. Thomas. American Public Health Association Annual Meeting, October 31, 2011, Washington, DC.
  • Poster: Sex-Differences in Exposure for FDA Approved New Molecular Entities (NMEs) 2007-2010: Exposure Based Dosing in Subgroup Populations. V Copeland, C Sahajwalla, A Parekh, 2011 American Association of Pharmaceutical Scientists annual meeting, Oct 23-27, 2011, Washington DC

September 2011

  • Presentation: Participation in Drug Trials - US FDA Perspective - Ameeta Parekh,
    Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities Conference, Sept 23, 2011, Washington DC
  • Presentation: Drug Safety – Is It Different For Men and Women? - Emmanuel Fadiran, American College of Clinical Pharmacology, 40th Annual Meeting, Sept 9 - 13, 2011, Chicago, IL

August 2011

  • Presentation: Sex-Specific reporting of scientific research -US FDA perspective, Ameeta Parekh. IOM sponsored workshop on Sex-Specific Reporting of Scientific Research, August 30, 2011, Washington, DC
  • Presentation: FDA Office of Women’s Health Overview, Ameeta Parekh, 40th Anniversary National Center for Toxicological Research (NCTR), August 10, 2011, Little Rock, AK.
  • Presentation: Regulatory Impact of Funded Research on Women’s Health, Emmanuel Fadiran. 40th Anniversary National Center for Toxicological Research (NCTR), August 10, 2011, Little Rock, AK

June 2011

  • Presentation: FDA Office of Women’s Health Pregnancy Exposure Registry Website. B. Gallauresi, The American Academy of Nurse Practitioners Annual Meeting, June 24, 2011, Las Vegas, NV
  • Presentation: HRSA’s Patient Safety and Clinical Services Collaborative - Karen C. Williams (HRSA) and Beverly Gallauresi (FDA) American Academy of Nurse Practitioners Annual Meeting, June 24, 2011, Las Vegas, NV
  • Poster: Participation of Women and Sex Analyses in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the FDA in 2007-2009. R Poon, K Khanijow, S Umarjee, E Fadiran, M Yu, L Zhang, A Parekh, Drug Information Association 2011 47th Annual Meeting, June 19-23, 2011, Chicago, IL
  • Poster: FDA Approved Drug Labels 2007-10: Dose Adjustments for Women Based on Exposure. V Copeland, A Parekh, Drug Information Association 2011 47th Annual Meeting, June 19-23, 2011, Chicago, IL
  • Poster: FDA Office of Women’s Health Funded Biological Studies: 1994-2010. M. Yu, A. Parekh, E. Fadiran, R. Poon, V. Copeland, Organization for the Study of Sex Differences (OSSD) Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
  • Poster: Women and ethnic minorities: a five year review of approved cardiovascular medical devices. Gallauresi, B; Khanijow, K; Umarjee, S; Parekh, A, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
  • Poster: FDA Office of Women’s Health Funded Extramural Pregnancy and Lactation Related Studies: 2001 – 2008. O. Laiyemo, A. Parekh, E. Fadiran, M. Yu, B. Gallauresi, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
  • Poster: Tracking Women’s Participation and Sex Analyses in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the FDA between 2007 and 2009. R Poon, K Khanijow, S Umarjee, E Fadiran, M Yu, Lei Zhang, A Parekh, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
  • Poster: An Overview of HIV Funded Studies by the FDA Office of Women’s Health. V Copeland, M Yu, E Fadiran, A Parekh, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK

May 2011

  • Presentation : "A Partner in Patient-Centered Care: Utilizing Resources from the FDA Office of Women's Health". Kimberly A. Thomas. HRSA Patient Safety and Clinical Pharmacy Services Collaborative (PSPC), Webcast - Learning Session #2, May 24, 2011.
  • Presentation: Marsha Henderson. 9th International Symposium on Osteoporosis - "Translating Research into Clinical Practice", May 20, 2011, Las Vegas, NV.
  • Presentation: Drug Exposures During Pregnancy - Role of Office of Women's Health, Ameeta Parekh, Pregnancy and Prescription Medication Use Symposium, FDA Office of Women’s Health, Silver Spring, MD, May 17, 2011

April 2011

  • Poster: FDA Office of Women’s Health Funded Breast Cancer Studies - 1994-2010. Michael Pazirandeh, Emmanuel Fadiran, Beverly Gallauresi, Ameeta Parekh: Women’s Health 2011, April 1-3, 2011, Washington DC
  • Poster: Participation of Women in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the Food and Drug Administration between 2007 and 2009. Rita Poon, Keshav Khanijow, Sphoorti Umarjee, Emmanuel Fadiran, Monica Yu, Lei Zhang, Ameeta Parekh; Women’s Health 2011; April 1-3, 2011, Washington DC.
  • Poster: Review of HIV Funded Studies by the FDA Office of Women’s Health (OWH). Vanessa Copeland, Monica Yu, Emmanuel Fadiran, Ameeta Parekh; Women’s Health 2011, April 1-3, 2011, Washington, DC

March 2011

  • Poster: Educating African American and Hispanic Women about Mammography. Kimberly A. Thomas. Fourth Health Disparities Conference - Xavier University of Louisiana College of Pharmacy, March 27-29, 2011.
  • Poster: Optimization of the Efficacy, Safety, and Risk/Benefit Review: Need for Early Integration of SDTM/ADaM Data Representations. A Szarfman, J Levine, CG Rochester, F Pucino, A Paredes, J Korvick, E Fadiran, J Norton, JM Tonning, J Diefenbach : DIA/CDER/CBER Computational Science Annual Meeting, March 14-15, 2011, Arlington, VA
  • Presentation: Bleeding, PCI and Women’s Health - Ameeta Parekh. TransRadial Education And Therapy (TREAT) II: A Cardiac Safety Critical Path Thinktank, March 7, 2011, FDA Headquarters - White Oak
  • Presentation: Marsha Henderson. Delta Day at the United Nations - Empowering Women and Girls Globally. March 4, 2011, New York, NY
  • Poster: A Five year review of approved cardiovascular medical devices: Are women and ethnic minorities adequately represented? Beverly Gallauresi, Keshav Khanijow, Sphoorti Umarjee, Ameeta Parekh. Cardiovascular Research Technologies (CRT) February 27–March 1, 2011, Washington, DC

February 2011

  • Presentation: Marsha Henderson. Health Forum: "Making Health Care Work for Our Communities". Delta Days in the Nation’s Capital 2011, February 7, 2011, Washington, DC

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November 2010

  • Panel Discussion: Ethnic Sensitivity in PK/PD: Leveraging Clinical Development in Emerging Countries – Using Knowledge of Ethnic Differences to Facilitate Drug Development - Ameeta Parekh. American Association of Pharmaceutical Sciences Annual Meeting and FIP PSWC, November 18, 2010
  • Poster: Review of Oncology Studies Funded by the FDA Office of Women’s Health – 1994-2007. Tien Nguyen, Emmanuel Fadiran, Ameeta Parekh, Joint FIP/AAPS Annual Meeting, November 14-18, 2010
  • Poster: FDA Office of Women’s Health Funded Biological Studies: 1994-2009 - A Summary Report. Monica Yu, Ameeta Parekh, Emmanuel Fadiran, Beverly Gallauresi, Salma Lemtouni, Keshav Khanijow, Sphortee Umarjee, Lauren DiPaola, Joint FIP/AAPS Annual Meeting, November 14-18, 2010.

October 2010

  • Presentation: The American Regulatory Perspective on Women in Clinical Trials - Ameeta Parekh. Karolinska Institute of Sweden, October 2010

September 2010

  • Keynote Speaker: Marsha Henderson, Session - Caring Women: Things Mama Forgot to Mention. AARP life@50+ Conference, September 30, 2010
  • Poster: Participation of Women in Clinical Trials: A Fifteen Year Assessment by the FDA Office of Women’s Health (OWH). Keshav Khanijow and Ameeta Parekh, Scientific Symposium: Celebrating the 20th Anniversary of the Office of Research on Women’s Health, NIH, September 27, 2010
  • Poster: The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies. Emmanuel Fadiran, Ameeta Parekh, and Kathleen Uhl, Scientific Symposium: Celebrating the 20th Anniversary of the Office of Research on Women’s Health, NIH, September 27, 2010
  • Presentation: FDA Office of Women’s Health Overview - Ameeta Parekh. NCTR Women’s Health Research Workshop on Sex Differences in FDA Regulated Products: Research for the Future, September 2, 2010
  • Presentation: FDA Data Standardization Initiatives: Implications for Demographics Analysis - Emmanuel Fadarin. NCTR Women’s Health Research Workshop on Sex Differences in FDA Regulated Products: Research for the Future, September 2, 2010

July 2010

  • Presentation: On Translating Science Into Regulatory Policy And Practices: The FDA View - Ameeta Parekh 22nd Annual Native Health Research Conference, July 28, 2010
  • Presentation: Women’s Faculty SIG Luncheon - Marsha Henderson. American Association of Colleges of Pharmacy Annual Meeting, July 11, 2010
  • Presentation: Promoting Wellness For Yourself and Those Who Need You - Alison Lemon. National Alliance on Mental Illness Annual Conference, July 3, 2010

June 2010

  • Presentation: FDA Office of Women’s Health Perspective - Beverly Gallauresi. Trans-radial Think Tank Meeting, June 23, 2010
  • Presentation: FDA Office of Women’s Health Pregnancy Exposure Registry Website - Beverly Gallauresi. American College of Nurse Midwives Annual Conference, June 14-15, 2010
  • Presentation: Supporting Nurse Midwives: Strengthening Women’s Health - Susana Perry. American College of Nurse Midwives Annual Conference, June 14-15, 2010
  • Poster: Using New Media to Deliver Health Information: A Twitter Pilot Project. Alison Lemon, Social Marketing in Public Health Conference, June 11-12, 2010
  • Presentation: An overview of the FDA Office of Women’s Health (OWH) funded Pregnancy studies and their impact - Beverly Gallauresi.Third International Conference for Individualized Pharmacotherapy in Pregnancy, June 7, 2010
  • Poster: FDA Office of Women’s Health Funded Studies on Medical Devices and Diagnostic Tests and Impact on Women’s Health- 1994-2009. Christopher Sheard, Emmanuel Fadiran, Ameeta Parekh, OSSD Annual Meeting, June 3-5, 2010

March 2010

  • Poster: Participation of Women in Clinical Trials: A fifteen year assessment by the FDA Office of Women’s Health (OWH). Keshav Khanijow, Ameeta Parekh, Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
  • Poster: FDA Office of Women’s Health Funded Oncology Studies - 1994-2009. Tien Nguyen, Emmanuel Fadiran, Ameeta Parekh, Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
  • Poster: The Patient Safety and Clinical Pharmacy Services Collaborative. Susana Perry, Krista Pedley (HRSA), Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
  • Poster: FDA Office of Women’s Health Intramural Funded Studies on Women’s Cardiovascular Health - 1994-2009. Christianah Kolajo, Emmanuel Fadiran, Salma Lemtouni, Ameeta Parekh, Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
  • Poster: The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case Studies. Emmanuel O. Fadiran, Ameeta Parekh and Kathleen Uhl, ASCPT 2010, March 17-20, 2010
  • Presentation: Women’s Participation in Clinical Trials: A Regulatory View - Ameeta Parekh. IOM Forum on Neuroscience and Nervous System Disorders, March 8-9, 2010
  • Poster: Information regarding the Pregnancy Exposure Registry Website. Beverly Gallauresi, Lauren DiPaola, Ameeta Parekh, Kathleen Uhl, Association of Maternal Child and Health Programs, March 6-10, 2010

February 2010

  • Poster: A review of recently approved cardiovascular medical devices: Are females adequately represented? Beverly Gallauresi; Sphoorti Umarjee; Keshav Khanijow; Ameeta Parekh; Kathleen Uhl, CRT 2010, February 21-23, 2010
  • Poster: Cardiovascular Studies Funded by Food and Drug Administration Office of Women’s Health - 1994-2009. Christianah Kolajo, Emmanuel Fadiran, Salma Lemtouni, Ameeta Parekh, CRT 2010, February 21-23, 2010
  • Poster: “It’s not what you say, it’s how you say it”: Promoting Public Health through Health Communication Materials from the FDA Office of Women’s Health. Alison Dingwall, American Academy of Health Behavior, February 7, 2010

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