*Program and presenters subject to change. Please check back frequently for updates.
Guest Speaker: Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC ### 609884###Guest Speaker###Principal Consultant###Salditt Regulatory Consulting LLC###Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hersGuest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hers @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
### @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Guest Speaker###Partner###NDA Partners###Guest Speaker: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
###Guest Speaker: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Lawrence E. Liberti, MSc, PhD ### 1046359###Guest Speaker###Head, Regulatory Collaborations######Guest Speaker: Lawrence E. Liberti, MSc, PhD
### @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho ### 1642067###Guest Speaker###Sr. Director, Reg. Affairs###QuidelOrtho###Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hersGuest Speaker: Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Guest Speaker###Partner###NDA Partners###Guest Speaker: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
### @@@ Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC ### 609884###Guest Speaker###Principal Consultant###Salditt Regulatory Consulting LLC###Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
###Guest Speaker: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Lawrence E. Liberti, MSc, PhD ### 1046359###Guest Speaker###Head, Regulatory Collaborations######Guest Speaker: Lawrence E. Liberti, MSc, PhD
###Facilitator: Sarah T. Michel, CSP (she/her/hers) – Velvet Chainsaw Consulting
### she/her/hers @@@ Bill McMoil – Regulatory Affairs Professionals Society (RAPS) ### 1083161###Guest Speaker###RAPS Executive Director###Regulatory Affairs Professionals Society (RAPS)###Guest Speaker: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
### @@@ Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023 ### 535468###Guest Speaker###Global Reg Policy & Intelligence and AdPromo###Planning Committee Chair Convergence 2023###Guest Speaker: Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific ### 1083158###Moderator###Director, Global Strategic Regulatory Affairs###Thermo Fisher Scientific###Moderator: Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific
### she/her/hers @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Guest Speaker###CSO###Qserve Group###Guest Speaker: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
### @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Panelist###Head of Scientific Advice###European Medicines Agency###Panelist: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ Amin Osmani, MSc – Cedience Inc. ### 2098346###Panelist###CEO###Cedience Inc.###Panelist: Amin Osmani, MSc – Cedience Inc.
### @@@ Amrit Ray, MD, MBA (he/him/his) – Principled Impact ### 2098157###Panelist###CEO###Principled Impact###Panelist: Amrit Ray, MD, MBA (he/him/his) – Principled Impact
### he/him/his @@@ Kelly Robinson – Health Canada ### 2135302###Panelist###Director General, Marketed Health Products Directorate###Health Canada###Panelist: Kelly Robinson – Health Canada
### @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: Janet Woodcock, MD – United States Food and Drug Administration
###Speaker: Linda McBride, R.PH, RAC – IAA Consulting LLC
###Speaker: Jocelyn Jennings – Mycovia Pharmaceuticals, Inc.
### @@@ William Sietsema, PhD (he/him/his) – Lisata Therapeutics ### 573564###Speaker###Vice President, Global Regulatory Affairs###Lisata Therapeutics###Speaker: William Sietsema, PhD (he/him/his) – Lisata Therapeutics
### he/him/hisSession Leader: Vada A. Perkins, MSc, MS, DRSc (c) – Bayer Pharmaceuticals
### @@@ Danielle Friend – Janssen ### 1698210###Presenter###Senior Director, US Head, Regulatory Policy and Intelligence###Janssen###Presenter: Danielle Friend – Janssen
### @@@ Virginia Hussong – FDA Center for Biologics Evaluation and Research ### 2064197###Presenter (Remote)###Branch Chief, Data Standards###FDA Center for Biologics Evaluation and Research###Presenter (Remote): Virginia Hussong – FDA Center for Biologics Evaluation and Research
### @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Presenter###Chief Regulatory Innovation Officer###Accumulus Synergy###Presenter: Khushboo Sharma, MBA – Accumulus Synergy
###Presenter: Monika Bhatt, LL.M, RAC (she/her/hers) – Siemens Healthineers
### she/her/hers @@@ Kenneth Fuh, PhD (he/him/his) – TÜV SÜD GmbH ### 1947083###Presenter###Product Assessment Expert###TÜV SÜD GmbH###Presenter: Kenneth Fuh, PhD (he/him/his) – TÜV SÜD GmbH
### he/him/his @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Moderator###Partner###Axon Lawyers###Moderator: Erik R. Vollebregt – Axon Lawyers
###Presenter: Antonella Lozito, PharmD – Moderna
### @@@ Immo Zdrojewski – Moderna ### 1946111###Presenter###Head Global Regulatory Policy and Regulatory Intelligence###Moderna###Presenter: Immo Zdrojewski – Moderna
###Session Leader: Kimberly A. Trautman, MS – MEDIcept
### @@@ Brian Siroka (he/him/his) – MEDIcept Inc. ### 1981335###Presenter###Associate Consultant###MEDIcept Inc.###Presenter: Brian Siroka (he/him/his) – MEDIcept Inc.
### he/him/his
