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Good Clinical Practices GCP Understanding and Implementing the Current Global Requirements 2017 Before 30 April 50% Discount for its All Seminars

Zurich, Switzerland  Switzerland - 15th Jun 2017

Course "Good Clinical Practices GCP Understanding and Implementing the Current Global Requirements" has been preapproved by RAPS as eligible for up to 12 credits towards a participants RAC recertification upon full completion. Overview: • Defining the basic requirements of Good Clinical Practices • Clinical Study Protocol Elements and Device Accountability • Role of Institutional Review Board IRB and Informed Consent • Principles of Ethics and Quality Control • Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial • Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials • Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection • Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials • And Much More... Why should you attend: • What is GCP and why is it needed? • History and development of GCP in EU and US and where are we now? • Managing problem areas of working with GCP regulations and guidelines • Impact of GCP globally and key FDA differences • Recognize the regulatory pathways in the U.S • Explore practical aspects of investigator and monitor selection • Discuss how to comply with the fundamentals of Good Clinical Practice GCP • Examine practical aspects of conducting international clinical trials • Understand the significance of Ethics and Human Subject Protection • Understand how to prepare for audit and inspection of clinical trials • Recognize what prompts an FDA audit • Learn how to plan for an audit or inspection, including using appropriate checklists • Appreciate how to prepare for auditinspection Interviews • Consider how to respond to the auditinspection findings • How to monitor clinical trials effectively and efficiently • Comprehensive overview of the applicable regulations on good clinical practice and clinical trials • Attendees are encouraged to discuss GCP work related activities associated with their functional area on the various topics as applicable for interactive group discussion • Review and discuss pain points, challenges and solutions Areas Covered in the Session: • Adherence to ethical principles as laid out by the Helsinki Declaration • Good Clinical Practice regulations require that clinical trials be consistent with regulatory requirements • Good Clinical Practice regulations require the sponsor to make available clinical and nonclinical data from the study to support further related research • Trials should thoroughly assess the risks and benefits inherent in a clinical research • The clinical research should ensure the wellbeing of its subjects • Good Clinical Practice regulations require sponsors of a clinical trial to contain a clearly defined protocol that should be rooted in established scientific principles and practices • A clinical research program must be subject to oversight from an independent Ethics Committee • Good Clinical Practice regulations requires the sponsor to obtain informed consent from each of the subjects • Good Clinical Practice regulations requires adherence to set documentation practices • There should be thorough confidentiality of information relating to the subject • The adherence to applicable Good Manufacturing Practices GMP by the sponsors when it comes to the manufacture, storing and handling of investigational products is another requirement of Good Clinical Practice regulations • The principles of Good Clinical Practice regulations require the implementation of systems with procedures that bring about complete quality at every stage of the clinical trial • New Clinical Trials Regulation EU No. 5362014 repealing Directive 200120EC • GCP Regulations, Guidance and Additional Resources Who Will Benefit: This seminar will provide an overview and indepth snapshot of GCP regulations with a global overview. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the GCP process, including • Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it • Clinical Project Managers who are taking on a wider range of responsibilities and need to gain a greater understanding of the regulatory and practical issues involved in medical device clinical trials • Regulatory Affairs Professionals who may be new to the device industry or new to the clinical trials process • Clinical Investigators and Clinical Research Coordinators interested in gaining a broader understanding of their role and responsibilities and how these tasks relate to the overall research process • Regulatory Affairs Management • Regulatory Affairs Specialist • Auditors • Compliance Specialist • Clinical Affairs • Quality Assurance Management • Consultants Agenda: Day 1 Schedule Good Clinical Practices • Introductions and Background • What is GCP? • Why should we have GCP? ICH GCPFDA CFR GCP • The Basic Principles of FDA and ICH GCP • The 13 Basic Principles of ICH GCP • Key ICH Guidelines and FDA Resources • Compliance Guidance Manuals • Impact of ICH GCP in the US • FDA Acceptance of Foreign Studies • FDA GCP Regulation • FDA and International Regulations and Guidance Relating to Good Clinical Practice and Clinical Trials • FDA and Institutional Review Board IRBIndependent Ethics Committee IRBIEC • Responsibility of the IRBIEC • Subject Informed Consent Forms • Informed Consent of Trial Subjects • IRBIEC interactions with Sponsors and Investigators • FDAs IRB requirements • FDA Responsibilities of Sponsors and Investigators • Investigator Records and Reports and Other Required Documentation for Good Clinical Practices • Disqualification of a Clinical Investigators • ICH Sponsor Responsibilities • FDASpecific Sponsor Responsibilities • Working with Contract Research Organizations CROs • Trial Management • Data Management • Recordkeeping and Documentation • Compensation to Subjects and Investigators and Other Financial Considerations Exercise and Recap of Day 1 • Clinical and Data Management Discussions • Review of Regulatory Documents Day 2 Schedule Good Clinical Practices • Monitor Responsibilities • Complying with the Protocol, Amendments, SOP and Guidance • Fraud and Misconduct • Safety & Adverse Event Reporting • Clinical Trial Protocol and Amendments • Investigator Brochure Requirements • Essential Documents • Tips for Regulatory Inspections Common Findings • Bioresearch Monitoring Program BIMO • BIMO inspection metrics clinical investigators, IRBs, sponsors, etc. • Reporting Complaints Related to FDARegulated Clinical Trials • GCP Inspections • Additional FDA Guidelines and Resources Exercise and Recap of Day 2 • Clinical and Data Management Discussions • Review of Regulatory Documents DebriefAdjourn • Recap of topics and key discussion points and take away message • FAQs and latest trends Speaker David R. Dills Global Regulatory Affairs & Compliance Consultant David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for earlystage and established Class IIIIII device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIAs, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessmentsaudits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and AgencyCenter Reviewers regarding submission meetings and negotiations; clinical affairsCTM and provides regulatory submissions and postmarket project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines AgencyEMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a companys commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit MDSAP, UDI, and Digital MarketingPromotionAdvertising compliance strategies; lead efforts regarding AEIncident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multicountry product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devicesall aspects of SWSDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology IVT, publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 20052006 Strathmores Whos Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliancerelated articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills academic degrees include Environmental Science and Biology. He is a former Chair and Co Chair of ASQs Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups. Location: Zurich, Switzerland Date: June 15th & 16th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 OpfikonGlattbrugg, Switzerland. 41 44 828 50 50 Price: Register now and save $200. Early Bird Price: $1,695.00 Seminar Fee for One Delegate Until May 10, Early Bird Price: $1,695.00 From May 11 to June 10, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 40% Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 18004479407 Fax: 3022886884 Email: john.robinson@globalcompliancepanel.com Website: http:www.globalcompliancepanel.com Registration Link – http:www.globalcompliancepanel.comcontrolglobalseminars~product_id900976SEMINAR?worldconferencealerts_SEO Follow us on LinkedIn: https:www.linkedin.comcompanyglobalcompliancepanel Like us our Facebook page: https:www.facebook.comTrainingsAtGlobalCompliancePanel Follow us on Twitter: https:twitter.comGCPanel
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Switzerland All Events Zurich zurich, Switzerland Congress Center Basel Geneva Opfikon Lucerne Palazzo dei Congressi CICG International Congress Center of Geneva International Conference Centre Geneva zurich, Switzerland
 
   June  2017  
 
06th
Jun
Palo Alto Networks PwC and Palo Alto Networks Joint Event Zurich

PwC Zurich, Switzerland
Organizer - Palo Alto Networks
PwC Zurich, Switzerland
 
07th
Jun
Joint CHEST SGP Congress 2017

Congress Center Basel, Switzerland
Congress Center Basel, Switzerland
 
08th
Jun
Implementation in Cosmetics Products 2017

Opfikon, Switzerland
Organizer - GlobalCompliancePanel
Opfikon, Switzerland
 
15th
Jun
The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

Zurich, Switzerland, Switzerland
Zurich, Switzerland, Switzerland
 
15th
Jun
Good Clinical Practices GCP Understanding and Implementing the Current Global Requirements 2017 Before 30 April 50% Discount for its All Seminars

Zurich, Switzerland, Switzerland
Zurich, Switzerland, Switzerland
 
16th
Jun
Academics WorldThe 89th International Conference on Language, Literature and Culture ICLLC

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics World 134th International Conference on Mining, Material, and Metallurgical Engineering ICMMME

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics WorldThe 193rd International Academic Conference on Development in Science and Technology IACDST

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics WorldThe 198th International Academic Conference on Engineering, Technology and Innovations IACETI

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics WorldThe 188th International Conference on Nanoscience, Nanotechnology and Advanced Materials IC2NM

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics World 193rd International Conference on Science, Social Science and Economics IC3SE

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics WorldThe 198th International Conference on Artificial Intelligence and Soft Computing ICAISC

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics World 193rd International Conference on Environmental Science and Development ICESD

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics World 195th International Conference on Management and Information Technology ICMIT

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
16th
Jun
Academics World 195th International Conference on Recent Advances in Medical and Health Sciences ICRAMHS

Zurich, Switzerland
Organizer - Academics World
Zurich, Switzerland
 
19th
Jun
Seminar on Product Information for Medicinal Products in the EU 2017

Zurich, Switzerland
Zurich, Switzerland
 
20th
Jun
ICPIC 2017 International Conference on Prevention

International Conference Centre Geneva, Switzerland
Organizer - MCI Group
International Conference Centre Geneva, Switzerland
 
24th
Jun
Sixth International Conference on Cryptography and Information Security CRYPIS 2017

zurich, Switzerland, Switzerland
Organizer - CRYPIS
zurich, Switzerland, Switzerland
 
24th
Jun
Sixth International Conference on Digital Image Processing and Vision ICDIPV 2017

zurich, Switzerland
Organizer - icdipv
zurich, Switzerland
 
24th
Jun
9th International Conference on Wireless & Mobile Network WiMo 2017

Zurich, Switzerland
Organizer - WiMo 2017
Zurich, Switzerland
 
24th
Jun
Sixth International Conference on Cryptography and Information Security CRYPIS 2017,,,

zurich, Switzerland, Switzerland
Organizer - CRYPIS
zurich, Switzerland, Switzerland
 
24th
Jun
Sixth International Conference on Advanced Computer Science and Information Technology ICAIT 2017

Zurich, Switzerland
Organizer - ICAIT
Zurich, Switzerland
 
24th
Jun
Fifth International Conference of Networks and Communications NC 2017

Zurich, Switzerland
Organizer - nc
Zurich, Switzerland
 
24th
Jun
Sixth International Conference on Information Technology Convergence and Services ITCSE 2017

Zurich, Switzerland
Organizer - ITCSE 2017
Zurich, Switzerland
 
24th
Jun
Third International Conference on Biomedical Engineering and Science BIENS 2017

zurich, Switzerland
Organizer - BIENS
zurich, Switzerland
 
24th
Jun
Fourth International Conference on Electrical and Electronics Engineering ICEEE 2017

zurich, Switzerland
Organizer - ICEEE 2017
zurich, Switzerland
 
24th
Jun
Second International Conference on Mechanical Engineering & Applications MEAP 2017

zurich, Switzerland
Organizer - MEAP 2017
zurich, Switzerland
 
24th
Jun
Second International Conference on Bioscience & Engineering BIEN 2017

Zurich, Switzerland
Organizer - BIEN2017
Zurich, Switzerland
 
24th
Jun
2nd International Conference on Electrical Engineering ELEC 2017

Zurich, Switzerland
Organizer - ELEC 2017
Zurich, Switzerland
 
24th
Jun
https:www.xing.comevents2ndinternationalconferenceelectricalengineeringelec1819134?creationtrue

Zurich, Switzerland, Switzerland
Organizer - ELEC 2017
Zurich, Switzerland, Switzerland
 
24th
Jun
2nd International Conference on Electrical Engineering ELEC 2017

Zurich, Switzerland, Switzerland
Organizer - ELEC 2017
Zurich, Switzerland, Switzerland
 
28th
Jun
European Digital and Mobile Commerce Forum June 28 Zurich

Zurich Marriott Hotel, Switzerland
Zurich Marriott Hotel, Switzerland
   July  2017  
 
06th
Jul
21 CFR Part 11 compliance for software validation and SaaSCloud

Opfikon, Switzerland
Organizer - GlobalCompliancePanel
Opfikon, Switzerland
 
11th
Jul
Geneva International Conference on Advance Research 2017 GICAR 2107

Geneva, Switzerland
Geneva, Switzerland
 
11th
Jul
Geneva Economic Forum GEF 2017

Geneva, Switzerland
Geneva, Switzerland
 
12th
Jul
Validation and Part 11 Compliance of Computer Systems and Data 2017

Zurich, Switzerland, Switzerland
Zurich, Switzerland, Switzerland
 
17th
Jul
4th Addressing Europes Unfinished Business AEUB: Tackling polarization, building trust

Caux, Switzerland
Organizer - CauxIofC Foundation
Caux, Switzerland
   August  2017  
 
13th
Aug
WCS 2017 World Congress of Surgery by ISS SIC

Congress Center Basel, Switzerland
Organizer - PCO WCS 2017
Congress Center Basel, Switzerland
 
16th
Aug
ISERD – 231st International Conference on Science and Innovative Engineering ICSIE

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD 238th International Conference on Medical and Health Sciences ICMHS

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD – 232nd International Conference on Economics, Management and Social Study ICEMSS

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD 225th International Conference on Chemical and Biochemical Engineering ICCBE

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD 170th International Conference on Vehicular, Mobile and Wearable Technology ICVMWT

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD – 232nd International Conference on Recent Innovations in Engineering and Technology ICRIET

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD – 232nd International Conference on Environment and Natural Science ICENS

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD – 225th nternational Conference on Education and ELearning ICEEL

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
16th
Aug
ISERD 219th International Conference on Accounting and Finance ICAF

Zurich, Switzerland
Organizer - ISERD
Zurich, Switzerland
 
31st
Aug
International Conference on Tourism and Business ICTB 2017

Lucerne, Switzerland
Lucerne, Switzerland
   September  2017  
 
01st
Sep
2017 International Conference on Communication and Network Technology ICCNT 2017

Zurich, Switzerland
Organizer - ICCNT 2017
Zurich, Switzerland
 
01st
Sep
2017 International Conference on Intelligent Traffic and Transportation ICITT 2017

Zurich, Switzerland
Organizer - ICITT 2017
Zurich, Switzerland
 
01st
Sep
2017 International Conference on Communication and Network Technology ICCNT 2017

Zurich, Switzerland
Organizer - ICCNT 2017
Zurich, Switzerland
 
01st
Sep
2017 International Conference on Intelligent Traffic and Transportation ICITT 2017

Zurich, Switzerland
Organizer - ICITT 2017
Zurich, Switzerland
 
02nd
Sep
14th World Conference Global perspectives in Esophageal diseases

CICG International Congress Center of Geneva, Switzerland
Organizer - Symporg SA
CICG International Congress Center of Geneva, Switzerland
 
07th
Sep
CARF Luzern 2017 Controlling.Accounting.Risiko.Finanzen.

Luzern, Switzerland
Luzern, Switzerland
 
13th
Sep
36th Annual ESRA Congress 2017

Palazzo dei Congressi, Switzerland
Organizer - Kenes Group
Palazzo dei Congressi, Switzerland
   October  2017  
 
16th
Oct
The IIER 287th International Conference on Social Science and Economics ICSSE

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 287th International Conference on Social Science and Economics ICSSE

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 275th International Conference on Science, Innovation and Management ICSIM

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 275th International Conference on Science, Innovation and Management ICSIM

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 287th International Conference on Recent Innovations in Engineering and Technology ICRIET

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 282nd International Conference on Recent Advances in Medical Science ICRAMS

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 288th International Conference on Natural Science and Environment ICNSE

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 279th International Conferenceon Chemical and Biochemical EngineeringICCBE

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 280th International Conference on Applied Physics and Mathematics ICAPM

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 291st International Conference on Advances in Business Management and Information Technology ICABMIT

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 206th International Conference on Psychology, Language and Teaching ICPLT

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
16th
Oct
The IIER 180th International Conference on Law and Political ScienceICLPS

Zurich, Switzerland
Organizer - The IIER
Zurich, Switzerland
 
31st
Oct
European Antibody Congress

Congress Center Basel, Switzerland
Congress Center Basel, Switzerland
 
31st
Oct
World Biosimilar Congress 2017

Congress Center Basel, Switzerland
Organizer - Terrapinn
Congress Center Basel, Switzerland
 
31st
Oct
World Immunotherapy Congress 2017

Congress Center Basel, Switzerland
Organizer - Terrapinn
Congress Center Basel, Switzerland
   November  2017  
 
23rd
Nov
International Conference on Assessment & Feedback Practises for Higher Education

Zurich, Switzerland
Zurich, Switzerland
 
23rd
Nov
International Civil and Structure Engineering Research Conference

Zurich, Switzerland
Zurich, Switzerland
   December  2017  
 
04th
Dec
European Colorectal Congress 2017

OLMA Messen St.Gallen, St. Jakob Strasse, Switzerland
Organizer - Medkongress AG
OLMA Messen St.Gallen, St. Jakob Strasse, Switzerland
   July  2018  
 
01st
Jul
18th European Congress on Biotechnology: July 2018, Geneva

The International Conference Centre Geneva, Switzerland
Organizer - TFI Group
The International Conference Centre Geneva, Switzerland