Document text
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FDA-CBER-2021-5683-0000100
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FDA-CBER-2021-5683-0000109
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Audit Trail Report
Document Name C4591001_INV02-INV04-WI-GL02-SD01 2 0 Abb CV Temp_SerhatUNAL.pd f
Document ID 34af45ae-a8bb-49c1-8c6d-145f5e68bfad
Time Stamp User Action Details
DocUUID : 34af45ae-a8bb-49c1-8c6d-145f5e68bfad24 Aug 2020 11:49 009+0300Didem Erten
UUID : 62201ce7-9f30-4ba7-84b2-bded2517df4b Email : didem erten@iconplc comStartedThe custodian composed the ePak succesfully.Subject: C4591001 - INV02-INV04-WI-GL02-RF06 2.0PDPForm_Non-US Sites_SerhatUNALePak UUID: 77757b2b-2750-49bf-a203-762dd6ed0e22
24 Aug 2020 11:49 009+0300Serhat Unal UUID : 1ead0a44-c2d3-4ca0-a599-71a41dd0e2f8 Email : [email protected] trRequestSent Sign request sent to ePak recipient.
24 Aug 2020 12:01 022+0300Serhat Unal UUID : 1ead0a44-c2d3-4ca0-a599-71a41dd0e2f8 Email : [email protected] trDocumentViewed Document viewed by signer.
24 Aug 2020 12:01 036+0300Serhat Unal UUID : 1ead0a44-c2d3-4ca0-a599-71a41dd0e2f8 Email : [email protected] trSignedThe recipient signed the document with no comments. Comments: None Reason: I approve this document
24 Aug 2020 12:02 039+0300Didem Erten UUID : 62201ce7-9f30-4ba7-84b2-bded2517df4b Email : didem erten@iconplc comCompleted The ePak is completed successfully.ETMF Copy of: 270.01|C4591001|24-Aug-2020 | Active | 15-Feb-2021 10:23:23 AM|TURKEY|1205090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000111
FDA-CBER-2021-5683-0000112
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FDA-CBER-2021-5683-0000114
FDA-CBER-2021-5683-0000115
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FDA-CBER-2021-5683-0000117
FDA-CBER-2021-5683-0000118
FDA-CBER-2021-5683-0000119
FDA-CBER-2021-5683-0000120
MSB
Validation Report as of: 21 Aug 2020 09:29:052+0300
1
Subject CN MSB
Subject DN [email protected],CN=MSB,OU=MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=USEmail [email protected] # 103155442024134641897105422308128156249Issuer DN CN=Entrust Class 3 Client CA - SHA256,OU=(c) 2015 Entrust, Inc. - for authorized use only,OU=See www.entrust.net/legal-
terms,O=Entrust, Inc.,C=US
Signing Time 12 Aug 2020 19:32:027+0300
The Certificate chain was successfully built to a Trusted Root Certificate.
The Signer's identity is valid.
The Document has not been modified since the signature was appl ied.
This page was added to the original document by the MSB Validat ion Service (SVS) as part of the process to convert
active signature block content into inactive text. A full validation report of each signature is generated and cross-
referenced using a numeric footnote annotation.
DocUUID : 09193daa-32db-4d7f-ab7b-7fbedc7e46adETMF Copy of: 270.01|C4591001|12-Aug-2020 | Active | 15-Feb-2021 10:23:24 AM|TURKEY|1209090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000121
DocUUID : 09193daa-32db-4d7f-ab7b-7fbedc7e46ad12 Aug 2020 19 37:035+0300 Didem Erten Completed The ePak completed the workflow successfully custodian.
User UUID : 62201ce7-9f30-4ba7-84b2-bded2517df4b
User Email : didem.erten@iconplc comETMF Copy of: 270.01|C4591001|12-Aug-2020 | Active | 15-Feb-2021 10:23:24 AM|TURKEY|1209090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000122
FDA-CBER-2021-5683-0000123
MSB
Validation Report as of: 21 Aug 2020 09:19:001+0300
1
Subject CN MSB
Subject DN [email protected],CN=MSB,OU=MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=USEmail [email protected] # 103155442024134641897105422308128156249Issuer DN CN=Entrust Class 3 Client CA - SHA256,OU=(c) 2015 Entrust, Inc. - for authorized use only,OU=See www.entrust.net/legal-
terms,O=Entrust, Inc.,C=US
Signing Time 13 Aug 2020 15:15:007+0300
The Certificate chain was successfully built to a Trusted Root Certificate.
The Signer's identity is valid.
The Document has not been modified since the signature was appl ied.
This page was added to the original document by the MSB Validat ion Service (SVS) as part of the process to convert
active signature block content into inactive text. A full validation report of each signature is generated and cross-
referenced using a numeric footnote annotation.
DocUUID : 3b5a46bd-dcba-4ed4-a9fa-5ef239f45b50ETMF Copy of: 270.01|C4591001|13-Aug-2020 | Active | 15-Feb-2021 10:23:23 AM|TURKEY|1210090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000124
Audit Trail Report
Date User Document Action Details
DocUUID : 3b5a46bd-dcba-4ed4-a9fa-5ef239f45b5013 Aug 2020 14 50:018+0300 Didem Erten Started The custodian composed the ePak succesfully.
User UUID : 62201ce7-9f30-4ba7-84b2-bded2517df4b
User Email : didem.erten@iconplc com
13 Aug 2020 14 50:019+0300 Ali Mert RequestSent Sign request sent to ePak recipient.
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
13 Aug 2020 14 53:029+0300 Ali Mert C4591001_IP13-GSOP-RF01
4.0 MPSA Form_AliMERT pdfDocumentViewed Document viewed by signer.
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User Email : [email protected] tr
Document UU D : b9bf3516-141e-4c13-892e-04d501f98e28
13 Aug 2020 14 56:043+0300 Ali Mert C4591001 - INV02-INV04-WI-
GL02-RF06 2.0 PDPForm_Non-
US Sites_AliMERT.pdfDocumentViewed Document viewed by signer.
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UUID : ed9cf172-dcbe-4236-ab90-e954c92c8601
13 Aug 2020 15 00:047+0300 Ali Mert C4591001_INV02-INV04-WI-
GL02-RF08 3.0 Inv Protocol
Accept F_Prot Am
5_AliMERT.pdfDocumentViewed Document viewed by signer.
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
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13 Aug 2020 15:11:043+0300 Ali Mert C4591001_IP13-GSOP-RF01
4.0 MPSA Form_AliMERT pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UU D : b9bf3516-141e-4c13-892e-04d501f98e28
13 Aug 2020 15:12:038+0300 Ali Mert C4591001 - INV02-INV04-WI-
GL02-RF06 2.0 PDPForm_Non-
US Sites_AliMERT.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UUID : ed9cf172-dcbe-4236-ab90-e954c92c8601
13 Aug 2020 15:13:045+0300 Ali Mert C4591001_INV02-INV04-WI-
GL02-RF08 3.0 Inv Protocol
Accept F_Prot Am
5_AliMERT.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UUID : 754572c7-149d-4325-969f-ec581d944d12
13 Aug 2020 15:13:056+0300 Ali Mert C4591001_INV02-INV04-WI-
GL02-RF09 5 0 Inv ICHGCP
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Document UUID : b6abeeaa-9d9a-499f-a547-f766b533ff4d
13 Aug 2020 15:14:023+0300 Ali Mert C4591001_INV02-INV04-WI-
GL02-RF09 5 0 Inv ICHGCP
Attes Form_AliMERT.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UUID : b6abeeaa-9d9a-499f-a547-f766b533ff4d
13 Aug 2020 15:14:032+0300 Ali Mert C4591001_INV02-INV04-WI-
GL02-SD01 2.0 Abb CV
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Document UUID : 3b5a46bd-dcba-4ed4-a9fa-5ef239f45b50
13 Aug 2020 15:15:008+0300 Ali Mert C4591001_INV02-INV04-WI-
GL02-SD01 2.0 Abb CV
Temp_AliMERT.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UUID : 3b5a46bd-dcba-4ed4-a9fa-5ef239f45b50
13 Aug 2020 15:15:017+0300 Ali Mert IB AoR_AliMERT.pdf DocumentVie wed Document viewed by signer.
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UU D : 75f6eb7f-cfd8-4250-9ef3-cda182f1cbce
13 Aug 2020 15:15:046+0300 Ali Mert IB AoR_AliMERT.pdf Signed The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UU D : 75f6eb7f-cfd8-4250-9ef3-cda182f1cbce
13 Aug 2020 15:15:055+0300 Ali Mert C4591001_SQT_Financial-
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13 Aug 2020 15:17:025+0300 Ali Mert C4591001_SQT_Financial-
Disclosure_2019_Version-
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Document UU D : f0b0ace6-e3a6-4dcd-98a4-eaf9ad853611
13 Aug 2020 15:17:025+0300 Ali Mert C4591001_SQT_Financial-
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13 Aug 2020 15:17:025+0300 Ali Mert C4591001_SQT_Financial-
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13 Aug 2020 15:17:025+0300 Ali Mert C4591001_SQT_Financial-
Disclosure_2019_Version-
3 2_AliMert.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: I approve this document
User UU D : 95fb30b7-a4e1-4dac-925e-42cd84bad3ad
User Email : [email protected] tr
Document UU D : f0b0ace6-e3a6-4dcd-98a4-eaf9ad853611ETMF Copy of: 270.01|C4591001|13-Aug-2020 | Active | 15-Feb-2021 10:23:23 AM|TURKEY|1210090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000125
DocUUID : 3b5a46bd-dcba-4ed4-a9fa-5ef239f45b5013 Aug 2020 15:17:025+0300 Didem Erten Completed The ePak completed the workflow successfully custodian.
User UUID : 62201ce7-9f30-4ba7-84b2-bded2517df4b
User Email : didem.erten@iconplc comETMF Copy of: 270.01|C4591001|13-Aug-2020 | Active | 15-Feb-2021 10:23:23 AM|TURKEY|1210090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000126
FDA-CBER-2021-5683-0000127
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FDA-CBER-2021-5683-0000134
FDA-CBER-2021-5683-0000135
FDA-CBER-2021-5683-0000136
MSB
Validation Report as of: 21 Aug 2020 09:37:056+0300
1
Subject CN MSB
Subject DN [email protected],CN=MSB,OU=MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=USEmail [email protected] # 103155442024134641897105422308128156249Issuer DN CN=Entrust Class 3 Client CA - SHA256,OU=(c) 2015 Entrust, Inc. - for authorized use only,OU=See www.entrust.net/legal-
terms,O=Entrust, Inc.,C=US
Signing Time 13 Aug 2020 09:35:053+0300
The Certificate chain was successfully built to a Trusted Root Certificate.
The Signer's identity is valid.
The Document has not been modified since the signature was appl ied.
This page was added to the original document by the MSB Validat ion Service (SVS) as part of the process to convert
active signature block content into inactive text. A full validation report of each signature is generated and cross-
referenced using a numeric footnote annotation.
DocUUID : 66c3c2a8-913f-4140-8ce9-120b4f59b52fETMF Copy of: 270.01|C4591001|13-Aug-2020 | Active | 15-Feb-2021 10:23:25 AM|TURKEY|1217090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000137
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ETMF Copy of:
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0000139
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FDA-CBER-2021-5683-0000141
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FDA-CBER-2021-5683-0000142
FDA-CBER-2021-5683-0000143
Pfizer CV for COVID
_Davis%20One%20Page%20CV%205.2020.pdf
8986d899f24dd703deb73ef98bf1a14c0bef93a0
MM / DD / YYYY
Completed
This document was requested on eregbinder.com and signed on prod.eregbinder.com
05 / 07 / 2020
10:19:33 UTC-5
Sent for signature to Matthew Davis ([email protected])from [email protected]: 24.169.90.114
05 / 07 / 202010:54:30 UTC-5
Viewed by Matthew Davis ([email protected])IP: 24.169.90.114
05 / 07 / 2020
10:55:12 UTC-5
Signed by Matthew Davis ([email protected])IP: 24.169.90.114
The document has been completed.
05 / 07 / 2020
10:55:12 UTC-5ETMF Copy of: 270.01|C4591001|07-May-2020 | Active | 15-Feb-2021 10:20:14 AM|UNITED STATES|1005090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
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FDA-CBER-2021-5683-0000145
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FDA-CBER-2021-5683-0000183
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020
Last Name First Name Middle Name
Full Name: AndersonCorey G
Professional Mailing Address
Street Address: 1492 S. Mill Ave. Suite 312 Other Street Address:
City: Tempe State/Province: AZ Country: USA Zip/Postal Code: 85281
Email Address: [email protected]
Academic Qualifications:
Degree and/or Certification Date (yyyy) Institution and/or Country
Medical Doctorate 1992-1996 Rosalind Franklin University of Science and Medicine
BSA- Nutrition 1987 -1992 University of Arizona
Medical License Number State/Province Country
25911 Arizona USA
Current Position at Study Site: Investigator
Start Date Title Institution or Company State/Province & Country
Tempe , AZ
Previous Relevant Positions Including Academic Appointments:
Start and End Dates Title Institution or Company Country
2013-2014 Chief Executive Officer Dedicated Clinical Research USA
2006-2010 Investigator Dedicated Phase 1, Inc USA
Brief Summary of Relevant Clinical Research Experience:
PI conducting clinical research Since 2006 and has the opportunity to work with many different specialty groups, thus providi ng many
therapeutics areas.
Signature: Signature Date: (dd-Mmm-yyyy)
I will update and resubmit my abbreviated CV if there are changes and particularly if there is any change in status which would
adversely affect the assessment of my suitability to conduct/participate in clinical studies.
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.Complion Document ID: 2362393
2016 Investigator Alliance for Multispecialty Research LLC ,
formerly Clinical Research ConsortiumETMF Copy of: 270.01|C4591001|08-Feb-2021 | Active | 17-Mar-2021 7:11:17 AM|UNITED STATES|1073090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000184
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Corey Anderson, MD Current Sponsor-Specific CVs updated
institution name "Expires:" 05 Feb 2022
Complion Document ID: 2362393
Statement of Testament: I reviewed the contents of this document
Electronic Signature for: Corey Anderson
Electronically Signed by: [email protected]
Date and Time of Signature: 08 Feb 2021 09:59 ESTComplion Document ID: 2362393ETMF Copy of: 270.01|C4591001|08-Feb-2021 | Active | 17-Mar-2021 7:11:17 AM|UNITED STATES|1073090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000185
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full LN aml
em:Nr PatelSuchet R
Pof sN iinfgml Mm nlnga AddoN iir
Street Address 1:
Meridian Clinical Research, LLC Street Address 2:415 Hooper Road
City: EndwellState/Province:New York Country:USAZip/Postal Code:13760
E: m n l AddoN iir iym.Nl@: co: N dQcf :
AcmdN:nc t um lnsncm.nfgir
DNaoN N m gd/fo CN o. nsncm.nfg Dm.N ( ))))b Igi.n .u.nfg mgd/fo Cfug.o)
Bachelor of Medicine 1990 BJ Medical College, India
Bachelor of Surgery 1990 BJ Medical College, India
MNdncml LncNgiN eu : S N o v.m.N/Pof pn gcN Cf ug.o)
217880-1 New York USA
CuooN g. Pfin .nfg m. v.ud) vn .Nr
v.mo. Dm .N Tn.lN Igi.n .u.nfg fo C f: ym g) v.m.N/Pof pn gcN & Cf ug.o)
2000 Investigator Meridian Clinical Research, LLC. NY, USA
PoNpnfu i R N lNpmg. Pfin .nf gi Igcludn ga Acm dN:nc Ayyfn g.: N g.ir
v.mo. mgd Egd Dm .Ni Tn.lN Igi.n .u.nfg fo C f: ym g) Cf ug.o)
2011 - Present Lab Director Endwell Family Physicians USA
2000 -Present Physician Endwell Family Physicians USA
2000 - Present Active Staff Wilson Medical Center USA
2000 to July 2019 Medical Director Regional Clinical Research,
IncUSA
1997- 2000 Family Practice Residency Guthrie Clinic, Robert
Packer HospitalUSA
1996 – 1997 Transitional Year Residency Frankford Hospital USA
Bon Ns v u ::m o) f s RN lNpmg. Cln gncml RNiNmoch ExyN onNgcNr
Has conducted out-patient clinical research studies for 20 + years in collaboration with countless pharmaceutical companies. Has been an Investigator or Sub Investigator in many trials, with a wide variety of therapeutic indications, including: migraine, diabetes, stress incontinence, osteoarthritis, hypertension, hyperlipidemia, osteoporosis, GERD, COPD, erectile dysfunction, smoking cessation, episodics, weight loss, vaccines, and RSV.
vnagm.uo Nr vnagm.uo N Dm.Nr ( d d - M : : - ))))b
I wn ll uydm .N mgd oN iuS: n . : ) m SSoN pnm.Nd CV n s . hN oN moN chmgaNi mgd ym o. nculmol) ns . hN oN ni mg) chm gaN ng i.m .ui whn ch wf uld
mdpNoi Nl) mssNc. .hN miiNii: N g. f s : ) iun .mSnln.) .f cfgduc./ym o. ncnym.N ng clngncml i.udn NiQ
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES
.
1112650Suchet R. Patel, MD Sponsor Current CV 26 Jun 2020 Expires 26 Jun 2022 Archived 26 Ju
n 2022ETMF Copy of: 270.01|C4591001|29-Jun-2020 | Active | 15-Feb-2021 10:22:05 AM|UNITED STATES|1077090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000186
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Suchet R. Patel, MD Sponsor Current CV 26 Jun 2020
Expires 26 Jun 2022 Archived 26 Jun 2022
Document ID: 1112650
Statement of Testament: I reviewed the contents of this document
Electronic Signature for: Suchet Patel
Electronically Signed by: [email protected]
Date and Time of Signature: 29 Jun 2020 12:27 EDT
1112650Suchet R. Patel, MD Sponsor Current CV 26 Jun 2020 Expires 26 Jun 2022 Archived 26 Ju
n 2022ETMF Copy of: 270.01|C4591001|29-Jun-2020 | Active | 15-Feb-2021 10:22:05 AM|UNITED STATES|1077090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000187
ETMF Copy of: 270.01|C4591001|08-Jun-2020 | Active | 15-Feb-2021 10:22:05 AM|UNITED STATES|1079090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000188
ETMF Copy of: 270.01|C4591001|16-Jan-2020 | Active | 15-Feb-2021 10:22:05 AM|UNITED STATES|1080090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000189
ETMF Copy of: 270.01|C4591001|16-Jan-2020 | Active | 15-Feb-2021 10:22:05 AM|UNITED STATES|1080090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000190
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full Name: ButcherMichael Bain
Professional Mailing Address
Street Address: Sterling Research Group, Ltd.
2230 Auburn Avenue, Level B Other Street Address:
City: Cincinnati State/Province: OH Country: USA Zip/Postal Code: 45219
Email Address: yyu.@ cerQ s.erlingresear@ ctorg
A@ademi@ / ualifi@ a.ions:
Degree and(or Cer.ifi@ a.ion Da. e )bbbbS Ins.i.u.ion and(or Coun.rb
M.F.A. 2006 New York Academy – USA
M.D. 1995 University of Cincinnati College of Medicine – USA
B.S. in Biology 1990 Davidson College – USA
Medi@ al Li@ ense Numyer v.a.e(Propin@ e Coun.rb
35. 070976OH USA
Curren. Posi.ion a. v.udb vi.e:
v.ar. Da.e Ti.le Ins.i.u.ion or Com& anb v.a.e(Propin@ e h Coun.rb
2017-Present Investigator Sterling Research Group, Ltd. OH – USA
Prepious Relepan. Posi.ions In@ luding A@ ademi@ A&&oin.men.s:
v.ar. and End Da.es Ti.le Ins.i.u.ion or Com& anb Coun.rb
2014 – Present Associate Professor University of Cincinnati –
College of Medicine & DAAPUSA
2012 – 2014 Adjunct Faculty – Fine Arts Maryville College USA
2007 - 2011 Painting & Drawing InstructorUniversity of Tennessee USA
2006 – Present Independent Painting & Drawing InstructorBain Butcher Studio USA
Brief vummarb of Relepan. Clini@ al Resear@ c Ex& erien@ e:
3 years’ experience in clinical research as a Principal Investigator primarily in the areas of vaccine, pain, weight loss, internal medicine
vigna.ure: vigna. ure Da. e: )dd-Mmm-bbbbS
I will u& da.e and resuymi. mb ayyrepia.ed CV if .cere are @ canges and & ar.i@ ularlb if .cere is anb @ cange in s.a.us wci@ c would
adperselb affe@ . .ce assessmen. of mb sui.ayili.b .o @ ondu@ .( &ar.i@ i&a.e in @ lini@al s.udiest
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.
1028148 C4591001 Auburn Butcher, Bain Study Specific CV 28 May 2020 28 May 2022ETMF Copy of: 270.01|C4591001|29-May-2020 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1081090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000191
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: C4591001 Auburn Butcher, Bain Study Specific CV 28 May
2020 28 May 2022
Document ID: 1028148
Statement of Testament: I approved the contents of this document
Electronic Signature for: Bain Butcher
Electronically Signed by: [email protected]
Date and Time of Signature: 29 May 2020 11:31 EDT
1028148 C4591001 Auburn Butcher, Bain Study Specific CV 28 May 2020 28 May 2022ETMF Copy of: 270.01|C4591001|29-May-2020 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1081090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000192
DE
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(b) (6)
FDA-CBER-2021-5683-0000193
ETMF Copy of: 270.01|C4591001|28-May-2019 | Active | 15-Feb-2021 10:20:55 AM|UNITED STATES|1083090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000194
ETMF Copy of: 270.01|C4591001|15-Apr-2019 | Active | 15-Feb-2021 10:20:55 AM|UNITED STATES|1084090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000195
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 2INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full Name: FullerGregory M
Professional Mailing Address
Street Address:
300 N. Rufe Snow Dr.Other Street Address:
City: KellerState/Province:TXCountry:USAZip/Postal Code:76248
Email Address: gregoryfuller. @ enca@ iaresearQ t/ Qom
AQademiQ ( ualifiQ acions:
Degree and)or CercifiQ acion Dace b yyyyS Inscicucion and)or Councry
Residency/Chief Resident – Family Medicine1990 Goppert Family Care Center, USA
Doctorate of Medicine 1987 University of Arkansas College of Medicine, USA
Bachelors of Arts, Chemistry 1982 Baylor University, USA
MediQ al LiQ ense Numver pcace)Pro@ inQ e Councry
H8646 Texas USA
Currenc Posicion ac pcudy pice:
pcarc Dace Ticle Inscicucion or Com& any pcace)Pro@ inQe h Councry
Dec 2017 Principal Investigator Ventavia Research Group, LLC TX, USA
Pre@ ious Rele@ anc Posicions InQ luding AQ ademiQ A&&oincmencs:
pcarc and End Daces Ticle Inscicucion or Com& any Councry
1991 – 1995 Principal Investigator North Hills Family Medicine
(Research)USA
1990 – Present Physician North Hills Family Medicine USA
Brief pummary of Rele@ anc CliniQ al ResearQ t Ex& erienQ e:
Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula with Oligosaccharides;
A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Adminis tered
Intravenously in Subjects Experiencing An Acute Attack of Migraine;A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regiment of V114 in Healthy Infants (PNEU-PED);A Phase 3, Randomized, Open-Label Trial to Evaluate the Safety and Immunogenicity of A 20-Valent Pneumococcal Conjugate Vaccine in
Adults with Prior Pneumococcal VaccinationA Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of A 20-Valent Pneumococcal Conjugate Vacci ne
in Pneumococcal Vaccine-Naïve Adults 18 years of Age and Older;A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy
Subjects 6 Months Through 47 Months;An Assessment of the Safety of Pediatric Ibuprofen;A Phase IIIB FDA Study Jan 1995. XXX-XX Nasal Spray Study;A Phase IV Study to Evaluate the Efficacy of a Second Sumatriptan Succinate Tablet (25mg or 50mg in the Acute Treatment of Migr aine;
A Phase III Comparative Study of XXX vs. XXX in the Treatment of Community Acquired Pneumonia;A Phase III Study to Compare the Safety of XXX with Ibuprofen for the Long-Term Treatment of Osteoarthritis;A Phase III Comparison and Efficacy of XXX 400mg a day for 10 days vs. XXX 500mg BID for the Treatment of Patients with Communi ty
Acquired PneumoniaA Phase IV Efficacy of XXX for IBS;A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vacci ne
Given With, Or Separately From, 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants;
pignacure:
pignacure Dace: b dd-Mmm-yyyyS
I will u& dace and resuvmic my avvre@ iaced CV if ct ere are Q t anges and & arciQ ularly if ct ere is any Q t ange in scacus wt iQ t would
ad@ersely affeQ c ct e assessmenc of my suicavilicy co Q onduQ c)&arciQ i&ace in Q liniQal scudies/
1011004 Gregory Fuller Pfi zer CV Current CV 21May 2020Expired 20May 201 1035474 Abbre viated Curriculu mVitae ,Fuller Central Re movedFile 20May 2020ETMF Copy of: 270.01|C4591001|22-May-2020 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1085090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000196
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 2 of 2INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.
1011004 Gregory Fuller Pfi zer CV Current CV 21May 2020Expired 20May 201 1035474 Abbre viated Curriculu mVitae ,Fuller Central Re movedFile 20May 2020ETMF Copy of: 270.01|C4591001|22-May-2020 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1085090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000197
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
1035474 Abbre viated Curriculu mVitae ,Fuller Central Re movedFile 20May 2020ETMF Copy of: 270.01|C4591001|22-May-2020 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1085090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000198
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Gregory Fuller Pfizer CV Current CV 21 May 2020 Expired
20 May 2021
Document ID: 1011004
Statement of Testament: I approved the contents of this document
Electronic Signature for: Gregory Fuller
Electronically Signed by: [email protected]
Date and Time of Signature: 22 May 2020 09:50 CDT
1011004 Gregory Fuller Pfi zer CV Current CV 21May 2020Expired 20May 201 1035474 Abbre viated Curriculu mVitae ,Fuller Central Re movedFile 20May 2020ETMF Copy of: 270.01|C4591001|22-May-2020 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1085090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000199
ETMF Copy of: 270.01|C4591001|11-Mar-2021 | Active | 17-Mar-2021 7:12:11 AM|UNITED STATES|1087090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000200
ETMF Copy of: 270.01|C4591001|11-Mar-2021 | Active | 17-Mar-2021 7:12:11 AM|UNITED STATES|1087090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000201
ETMF Copy of: 270.01|C4591001|01-May-2020 | Active | 15-Feb-2021 10:20:55 AM|UNITED STATES|1087090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000202
FDA-CBER-2021-5683-0000203
ETMF Copy of: 270.01|C4591001|07-Jul-2020 | Active | 15-Feb-2021 10:22:08 AM|UNITED STATES|1089090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000204
ETMF Copy of: 270.01|C4591001|23-May-2018 | Active | 16-Mar-2021 6:24:51 AM|UNITED STATES|1090090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000205
ETMF Copy of: 270.01|C4591001|31-Jul-2018 | Active | 15-Feb-2021 10:20:58 AM|UNITED STATES|1090090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000206
ETMF Copy of: 270.01|C4591001|03-Jun-2020 | Active | 15-Feb-2021 10:22:06 AM|UNITED STATES|1091090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000207
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full Name: Davit Rajesh Kumar
Professional Mailing Address
Street Address: Sterling Research Group, Ltd.
375 Glensprings Drive, 2nd Floor Other Street Address: N/A
City: Cincinnati State/Province: OH Country: USA Zip/Postal Code: 45246
Email Address: [email protected] torg
Academic / ualifica.ions:
Degree and(or Cer.ifica.ion Da. e )bbbbS Ins.i.u.ion and(or Coun.rb
Doctor of Medicine 2002 St. Eustatius University, School of Medicine – UK
B.S. in Podiatry 1997 University of Wales, Institute Cardiff – UK
Medical License Numver p.a.e(Proyince Coun.rb
35.090620OH USA
Curren. Posi.ion a. p.udb pi.e:
p.ar. Da.e Ti.le Ins.i.u.ion or Com& anb p.a.e(Proyince h Coun.rb
2012 Investigator Sterling Research Group, Ltd. OH – USA
Preyious Releyan. Posi.ions Including Academic A& & oin.men.s:
p.ar. and End Da.es Ti.le Ins.i.u.ion or Com& anb Coun.rb
2008 – Present Family Physician Mercy Health Physicians USA
2008 – Present Emergency Physician Fort Hamilton Hospital USA
2007 – Present Peer / Medical Reviewer Journal of Urgent Care
MedicineUSA
2005 - 2008 Family Medicine Residency Greenville Hospital System
University Medical CenterUSA
Brief pummarb of Releyan. Clinical ResearcQ Ex& erience:
19 years’ clinical research experience as a Principal and or Sub-Investigator primarily in the areas of vaccine, dermatology, arthritis, pain, anti-infective, device, heart failure & weight loss, hyperlipidemia, hypertension, diabetes.
pigna.ure:
pigna. ure Da. e: )dd-Mmm-bbbbS
I will u& da.e and resuvmi. mb avvreyia.ed CV if .Q ere are cQ anges and & ar.icularlb if .Q ere is anb cQ ange in s.a.us wQ icQ would
adyerselb affec. .Q e assessmen. of mb sui.avili.b .o conduc.(& ar.ici& a.e in clinical s.udiest
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.
1092649 C4591001 Sprin gdale Davit, Rajesh Study Specific CV 22 Jun 2020 22 Jun 2022ETMF Copy of: 270.01|C4591001|23-Jun-2020 | Active | 15-Feb-2021 10:22:11 AM|UNITED STATES|1092090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000208
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: C4591001 Springdale Davit, Rajesh Study Specific CV 22
Jun 2020 22 Jun 2022
Document ID: 1092649
Statement of Testament: I approved the contents of this document
Electronic Signature for: Rajesh K Davit
Electronically Signed by: [email protected]
Date and Time of Signature: 23 Jun 2020 08:53 EDT
1092649 C4591001 Sprin gdale Davit, Rajesh Study Specific CV 22 Jun 2020 22 Jun 2022ETMF Copy of: 270.01|C4591001|23-Jun-2020 | Active | 15-Feb-2021 10:22:11 AM|UNITED STATES|1092090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000209
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020
N
Last Name First Name Middle Name
Full Name: EnszDavid Jon
Professional Mailing Address
Street Address:
4802 Sunnybrook DriveOther Street Address:
City: Sioux CityState/Province:IACountry:USAZip/Postal Code:51106
Email Address: [email protected]
Academic Qualifications:
Degree and/or Certification Date (yyyy) Institution and/or Country
Family Practice 2008 University of Nebraska Medical Center / USA
Doctor of Medicine 2005 University of Nebraska Medical Center / USA
Bachelor of Science 2001 Wayne State College / USA
Medical License Number State/Province Country
7873 SD USA
23832 NE USA
MD-38811 IA USA
FE2331685 National USA
Current Position at Study Site:
Start Date Title Institution or Company State/Province & Country
2010 Principal Investigator Meridian Clinical Research, LLC IA / USA
Previous Relevant Positions Including Academic Appointments:
Start and End Dates Title Institution or Company Country
2010 – Present Principal Investigator Meridian Clinical Research,
LLCUSA
2006 – Present Sub-Investigator Meridian Clinical Research, LLCUSA
Brief Summary of Relevant Clinical Research Experience
Endocrinology- Diabetes Mellitus Type I & Type II Genitourinary- Overactive Bladder, NocturiaDermatologic- Acne Vulgaris Respiratory- Asthma, COPDGastrointestinal- Irritable Bowel Syndrome C & D, GERD Cardiovascular- HypertensionHealthy Adult & Pediatric Vaccine Trials Healthy Adult TrialsInfectious- Herpes Simplex Labialis, Common Cold Neuropathic- Migraines, Restless Leg SyndromeMusculoskeletal- Fibromyalgia, Chronic Lower Back Pain, Osteoarthritis
Signature: Signature Date: (dd-Mmm-yyyy)
I will update and resubmit my abbreviated CV if there are changes and particularly if there is any change in status which would adversely affect the assessment of my suitability to conduct/participate in clinical studies.
OTE: H EI S C VM U BCE L: DS U S E: F ET EI : S ORTPU AES TO S O EI S C E: U - DAE: RTP S OVDBCS TO S O EI : S VI 3 : Y
VTU - DS AOE VDS OS VAD CEBF. P: - TPEN ALLP: M S AE: F VM ’C VAO L: OT UTP: EI AO Y - AG: C , FT OTE S OVD BF:
AEEAVI U : OEC TP E: XE TO P: M : PC: - AG: CNComplion Document ID: 1789241ETMF Copy of: 270.01|C4591001|10-Nov-2020 | Active | 17-Mar-2021 7:12:22 AM|UNITED STATES|1093090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000210
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: David Jon Ensz, MD Pfizer One Page Current CV 09 Nov
2020 Expires 09 Nov 2022 Archived
Complion Document ID: 1789241
Statement of Testament: I approved the contents of this document
Electronic Signature for: David Ensz, MD
Electronically Signed by: [email protected]
Date and Time of Signature: 10 Nov 2020 12:00 CSTComplion Document ID: 1789241ETMF Copy of: 270.01|C4591001|10-Nov-2020 | Active | 17-Mar-2021 7:12:22 AM|UNITED STATES|1093090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000211
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020N
Last Name First Name Middle Name
Full Name: EnszDavid Jon
Professional Mailing Address
Street Address:
330 Dakota Dunes Blvd.Other Street Address:Suite 400
City: Dakota DunesState/Province:SDCountry:USAZip/Postal Code:57049
Email Address: [email protected]
Academic Qualifications:
Degree and/or Certification Date (yyyy) Institution and/or Country
Family Practice 2008 University of Nebraska Medical Center / USA
Doctor of Medicine 2005 University of Nebraska Medical Center / USA
Bachelor of Science 2001 Wayne State College / USA
Medical License Number State/Province Country
7873 South Dakota USA
Current Position at Study Site:
Start Date Title Institution or Company State/Province & Country
2010 Principal Investigator Meridian Clinical Research, LLC SD / USA
Previous Relevant Positions Including Academic Appointments:
Start and End Dates Title Institution or Company Country
2010 – Present Principal Investigator Meridian Clinical Research,
LLCUSA
2006 – Present Sub-Investigator Meridian Clinical Research, LLCUSA
Brief Summary of Relevant Clinical Research Experience
Chronic Pain – Fibromyalgia, Chronic Lower Back Pain Healthy Adult Vaccine TrialsEndocrine – Diabetes Mellitus Type I, Diabetes mellitus Type II Pediatric Vaccine TrialsGastrointestinal – Irritable Bowel Syndrome, Constipation MigraineInfectious – Herpes Labialis, Common Cold Dermatologic - Acne
Signature:
Signature Date: (dd-Mmm-yyyy)
I will update and resubmit my abbreviated CV if there are changes and particularly if there is any change in status which would
adversely affect the assessment of my suitability to conduct/participate in clinical studies.
OTE: H EI S C VM U BCE L: DS U S E: F ET EI : S ORTPU AES TO S O EI S C E: U - DAE: RTP S OVDBCS TO S O EI : S VI 3 : Y
VTU - DS AOE VDS OS VAD CEBF. P: - TPEN ALLP: M S AE: F VM ’C VAO L: OT UTP: EI AO Y - AG: C , FT OTE S OVD BF:
AEEAVI U : OEC TP E: XE TO P: M : PC: - AG: CN
888496David Jon Ensz, MD Pfizer One Pa ge Current CV 15 Apr 2020 Expires 15 Apr 2022 Archiv
ed 15 Apr 2022ETMF Copy of: 270.01|C4591001|21-Apr-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1093090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000212
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: David Jon Ensz, MD Pfizer One Page Current CV 15 Apr
2020 Expires 15 Apr 2022 Archived 15 Apr 2022
Document ID: 888496
Statement of Testament: I approved the contents of this document
Electronic Signature for: David Ensz, MD
Electronically Signed by: [email protected]
Date and Time of Signature: 21 Apr 2020 10:06 CDT
888496David Jon Ensz, MD Pfizer One Pa ge Current CV 15 Apr 2020 Expires 15 Apr 2022 Archiv
ed 15 Apr 2022ETMF Copy of: 270.01|C4591001|21-Apr-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1093090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000213
ETMF Copy of: 270.01|C4591001|10-Jul-2020 | Active | 15-Feb-2021 10:22:13 AM|UNITED STATES|1094090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000214
FDA-CBER-2021-5683-0000215
ETMF Copy of: 270.01|C4591001|03-Feb-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1096090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000216
FDA-CBER-2021-5683-0000217