BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: \;Wednesday 2nd &\; Thursday 3rd October 2024\nTim e: \;Day 1: 09:00-17:00 | \;Day 2: \;09:00-16:00 BST\nLocation : \;This Course will be taught in-person\, at Crowne Plaza London Heat hrow T4 \;(Terminal 4\, Swindon Road\, Hounslow\, TW6 3FJ\, United Kin gdom)\nSpeakers: \;Dan Evans (DMK2 Consulting Limited)\, \;Ines An tunes dos Reis \;(MHRA)\, Yolanda Barbachano \;(BioNTech) and Kerr y Gordon \;(Phastar).\n\nWho is this event intended for? \;Statist icians who would like to enhance their knowledge of the latest ICH and oth er global and regional regulatory guidelines. \;\nWhat is the benefit of attending? \;Participants will either gain or expand upon their kno wledge and awareness of the regulatory environment and associated guidelin es.\nCost\nEarly Bird PSI Members = \;£\;370+VAT\nPSI Members = & pound\;410+VAT\n\nEarly Bird Non-Members \;= £\;480+VAT\nNon-Memb ers = £\;520+VAT\n*Please note: \;Non-Member rates include PSI me mbership until 31 Dec. 2025.\n\nRegistration\nTo book your place\, please click here.\n\nPlease note:\n- There are a limited number of places for th is in-person event. Due to its popularity\, we do kindly ask you to consid er both the timings and location before committing to attend.\n- \;Reg istration does not include hotel accommodation. \;If a hotel is requir ed (as this Course runs over two consecutive days)\, delegates will need t o book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4\, we recommend booking your accommodat ion here. Additionally\, there is a daily charge for parking\, which can a lso be booked with the Reservations team. To make your booking\, please co ntact the Crowne Plaza reservations team via the following:\nEmail: \; Reservations5@cpheathrowt4.com\nTelephone: \;0203 971 4182 \;or&nb sp\;0203 971 4181\nOverview\nThe course will describe key ICH guidelines o f main interest to statisticians\, as well as guidance documents from regu latory bodies such as EMA\, FDA\, PMDA\, MHRA and CDE. \; The focus of the course will be on the content of ICH E9 (Statistical Principles for C linical Trials)\, ICH E9(R1) (Estimands and Sensitivity Analysis in Clinic al Trials)\, ICH E10 (Choice of Control Group in Clinical Trials)\, ICH E6 (Good Clinical Practice)\, ICH E17 (Multi-Regional Clinical Trials)\, and ICH E20 (Adaptive Clinical Trials)\, but other key regulatory guidance do cuments will also be highlighted. The course will also include workshops\, a Q&\;A session and guidance on how to seek advice from regulators.&nb sp\;\nSpeaker details\n\n\n\n \n \n \n Spe aker\n \n \n Biography\n \n \n \n \n \n \n \n \n \n \n \n \n \n Dan Evans\n Dan Evans has worked for Pfize r for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas.  \; He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years\, participating in the co-ordination of reviews of new r egulatory guidelines and policies and engagement on statistical topics wit h regulatory statisticians. He&rsquo\;s currently working as an independen t statistical consultant.\n \n \n \n \ n \n \n \n \n \n \n \n \n \n Inê\ ;s Antunes dos Reis\n \n \n Inê\;s h as been a statistical assessor at the Medicines and Healthcare products Re gulatory Agency (MHRA) since 2018. Her work focuses on assessment of marke ting authorisation applications\, providing scientific advice to companies \, assessment of clinical investigation applications\, and participating i n the development of regulatory guidelines. She has over 7 years of experi ence in the regulatory system\, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed t o the E9(R1) training materials published in the ICH website.\n \n \n \n \n \n Yolanda Bar bachano\n \n \n Yolanda has worked as a s tatistician for nearly two decades\, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance d eveloped whilst working over 10 years as a statistical assessor at the MHR A\, and as part of the EMA system. \n Yolanda now works at BioN Tech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics\, both from the Unive rsity of Sussex.\n \n \n \n \n \n Kerry Gordon\n \n \n Ke rry Gordon has been in the health sector for over 40 years\, mostly in the world of statistics and programming. As a past Chair of PSI\, Kerry has s at on the PSI Board of Directors and has also served on the PSI Scientific \, Website\, Regulatory and Training subcommittees. After starting out wit h the NHS\, he moved into the industry at (what is now) Novartis. Then\, a fter a spell at the University of Kent\, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHA STAR\, a niche Biometrics CRO\, in July last year as an Engagement Head\, looking after specific customer accounts.\n \n \n \n\ n \;\n \; DTEND:20241003T150000Z DTSTAMP:20260418T193905Z DTSTART:20241002T090000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Training Course: Regulatory Guidelines for Statisticians UID:RFCALITEM639121379454071200 X-ALT-DESC;FMTTYPE=text/html:Date: \; Wednesday 2nd &\; Thursday 3rd October 2024
\nTime: \;Day 1: 09:00-17 :00 | \;Day 2: \ ;09:00-16:00 BST
\nLocation: \;This Course will be taught in-person\, at Crowne Plaza London Heathrow T4 \;< em>(Terminal 4\, Swindon Road\, Hounslow\, TW6 3FJ\, United Kingdom)
\nSpeakers: \;Dan Evans (DMK2 Consulting Lim ited)\, \;Ines Antunes dos Reis \;(MHRA)\, Yolanda B arbachano \;(BioNTech) and Kerry Gordon \;(Phastar).
\n
\nWho is this event intended for? \ ;Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. \;
\nWhat is the benefit of attending? \;Participants will eithe r gain or expand upon their knowledge and awareness of the regulatory envi ronment and associated guidelines.
\n

Cost

\n

Early Bird PSI Members = \;£\;370+VAT
\nPSI Membe rs = £\;410+VAT
\n
\nEarly Bird Non-Member s \;= £\;480+VAT
\nNon-Members = & pound\;520+VAT
\n*Please note: \;Non-Member rates include PSI membership until 31 Dec. 2025.
\n

\n

Registration

\n< p>To book your place\, please click here< /a>.
\n
\nPl ease note:
\n- There are a limited number of places for this in-person event. Due to its popularity\, we do kindly ask you to consider both the timings and location before committing to attend.
\n- \;Registration does not include hotel accommodation. \;If a hotel is requir ed (as this Course runs over two consecutive days)\, delegates will need t o book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4\, we recommend booking your accommodat ion here. Additionally\, there is a daily charge for parking\, which can a lso be booked with the Reservations team. To make your booking\, please contact the Crowne Plaza reservations team via the following:
\nEmail: \;Reservations5@cpheathrowt4.co m
\nTelephone: \;0203 971 4182 \;or \;0203 971 4181

\n

Overvie w

\n

The course will describe key ICH guidelines of main interest to statisticians\, as well as guidance documents from regulatory bodies such as EMA\, FDA\, PMDA\, MHRA and CDE. \; The focus of the course will b e on the content of ICH E9 (Statistical Principles for Clinical Trials)\, ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials)\, ICH E 10 (Choice of Control Group in Clinical Trials)\, ICH E6 (Good Clinical Pr actice)\, ICH E17 (Multi-Regional Clinical Trials)\, and ICH E20 (Adaptive Clinical Trials)\, but other key regulatory guidance documents will also be highlighted. The course will also include workshops\, a Q&\;A sessio n and guidance on how to seek advice from regulators. \;< /p>\n

Speaker details

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Speaker

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Bio graphy

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\n Dan Evans		Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global devel opment of medicines across many therapeutic areas. \; He has a particu lar focus on statistical regulatory topics and has been an active member o f the PSI/EFSPI Regulatory Special Interest Group for over 15 years\, part icipating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticia ns. He&rsquo\;s currently working as an independent statistical consultant .
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\n Inê\;s Antunes dos Reis

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Inê\;s has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 20 18. Her work focuses on assessment of marketing authorisation applications \, providing scientific advice to companies\, assessment of clinical inves tigation applications\, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system\, having previously worked for the European Medicines Agency (EMA). She sup ported the ICH E9(R1) expert working group on Estimands and Sensitivity An alysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website.

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\n Yolanda Barbachano

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Yolanda has worked as a statistician for nearly two decades\, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working ove r 10 years as a statistical assessor at the MHRA\, and as part of the EMA system.

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Yolanda now works at BioNTech where she has t o consider regulatory requirements for other regions. She has a PhD in sta tistics and a BSc in mathematics\, both from the University of Sussex.

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Kerryedit
\ n Kerry Gordon

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Kerry Gordon has been in the health sector for over 40 years\, mostly in the world of statistics a nd programming. As a past Chair of PSI\, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific\, Website\, Regulator y and Training subcommittees. After starting out with the NHS\, he moved i nto the industry at (what is now) Novartis. Then\, after a spell at the Un iversity of Kent\, he worked for Quintiles (latterly IQVIA) for over 20 ye ars and at Parexel for a few years. Kerry joined PHASTAR\, a niche Biometr ics CRO\, in July last year as an Engagement Head\, looking after specific customer accounts.

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