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Thursday, June 28 • 9:00am - 10:30am
#415: EMA/FDA Question Time

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-696-L04-P; CME 1.50; IACET 1.50; RN 1.50

EMA and FDA leadership come together at a round table discussion on areas covered by the EMA/ FDA confidentiality arrangements and how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/ FDA cooperation will explore topics such as innovation support to industry, development of medicines for special populations, challenges on quality of medicines, and data transparency. The audience is invited to submit questions both on the topics explored and of general interest. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions in advance to annualmeetingprogram@diahome.org, and include “EMA/ FDA Question Time” in the subject line.

Learning Objectives

Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy and safety; Identify how to engage both agencies in the development of a medicine at the same time.

Chair

Tânia Teixeira, PharmD
Sandra L. Kweder, MD

Speaker

Challenges in Product Quality in Expedited Development Programs
Giuseppe Randazzo, MS

Challenges in Product Quality in Expedited Development Programs
Peter Richardson, PhD

Issues in Data Transparency
Ann M. Witt, JD

Issues in Data Transparency
Anne-Sophie Henry-Eude, PharmD

Tackling Challenges in Rare Disease Treatments
Lucas Kempf, MD

Tackling Challenges in Rare Disease Treatments
Kristina Larsson, MS

Pediatrics
Lynne P. Yao, MD

Pediatrics
Agnès Saint-Raymond, MD


Moderators
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →

Speakers
avatar for Anne-Sophie Henry-Eude

Anne-Sophie Henry-Eude

Head of Documents Access and Publication Service, European Medicines Agency (EMA)
Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans... Read More →
LK

Lucas Kempf

Acting Associate Director, Rare Diseases Program, OND, CDER, FDA
Dr. Lucas Kempf is the Acting Associate Director for the Rare Disease program in the OND immediate office. Prior to joining FDA in 2012, Lucas spent 8 years at NIH with a focus on neuroscience research, working to understand the genetics of neuropsychiatric disease and developing... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Kristina Larsson

Kristina Larsson

Head of Office for Orphan Medicines, European Medicines Agency (EMA)
Kristina Larsson joined the orphan team of the EMA as the Head of Office in July 2014. Before that she spent 8 years as a scientific officer in the scientific advice team of the EMA in charge of the Scientific Advice Working Party secretariat. Before joining the agency she worked... Read More →
avatar for Giuseppe Randazzo

Giuseppe Randazzo

Director, Office of New Drug Products, OPQ, CDER, FDA
Giuseppe serves as Director of the Office of New Drug Products (ONDP) in CDER at FDA. ONDP is responsible for conducting risk and team-based, quality assessments of INDs, NDAs, and active pharmaceutical ingredient (API) information supporting NDAs and ANDAs. Giuseppe has been at the... Read More →
avatar for Peter Richardson

Peter Richardson

Head of Quality, Specialised Scientific Disciplines Department, European Medicines Agency (EMA)
Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →
AW

Ann Witt

Counselor to DC for Policy, OND, CDER, FDA
Received my BA from Bryn Mawr College, and JD from Stanford Law School. After 1-year clerkship, came to work at FDA in 1980. Worked in the Office of Chief Counsel on new drug issues and the Office of the Commissioner until 2002, when I did an 8-year stint on Capitol Hill. Returned... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →

Thursday June 28, 2018 9:00am - 10:30am
Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: DIAmond, Forum