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Good Clinical Practices (GCP)

– Understanding and Implementing the Current Global Requirements

June 24 – 25, 2019

Mumbai, MH, India

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting studies that involve human participants. Attending this GCP course is an essential requirement for any researcher involved in commercial or non-commercial studies. Compliance with Good Clinical Practices principles provides assurance that the rights, safety and well-being of research subjects are protected and that the results of the study are credible. It is highly recommended that GCP training is updated often.

This two days training course designed to cover entire requirements of ICH E6, ICH E3 and Schedule Y and MHRA Good Clinical Practices requirements. To Meet the minimum criteria for International Conference on Harmonisation (ICH) GCP training including: GCP Overview, the Principles of ICH GCP and Investigator responsibilities, and to contribute in fulfilling The FDA expectations for study personnel training.

This seminar will provide an in-depth review of new applications and regulatory topics in clinical research, as well as provide practical tips to assist participants in understanding, applying and successfully complying with Good Clinical Practices guidelines. Professionals 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.

Who Should Attend:

  • Regulatory Affairs Management and Staff
  • Compliance Management and Staff
  • Clinical Affairs Management and Staff
  • Quality Assurance Management and Staff
  • Quality Control Management and Staff
  • Consultants
  • Auditors
  • Clinical Investigators
  • Clinical Research Associates
  • Clinical Project Managers
  • Clinical Study Coordinators
  • Clinical Data Management Teams
  • IT Personnel working on Clinical Systems

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

1. Introduction – Overview of the Drug Development process and Clinical Research

2. History of GCP and Clinical Trials Directive

3. GCP Principles

4. Investigator’s Brochure – Important considerations:

  • Physical, Chemical, Pharmaceutical Properties and Formulation
  • Nonclinical Studies and Effects in Humans
  • Summary of Data and Guidance for the Investigator

5. Ethical and safety considerations – key aspects:

  • Ethical Principles
  • Institutional Review Board/Independent Ethics Committee – Composition, Review Procedures and Decision Making Process, Record Keeping
  • Involving patients in clinical trials – Informed Consent Process
  • Essential Information on Confidentiality for Prospective Research Subjects
  • Compensation for Participation and Accidental Injury
  • Selection of Special Groups as Research Subject

6. Key Roles and Responsibilities of various stakeholders
Sponsor:

  • Trial Design, Management, Data Handling, and Record Keeping
  • Contract Research Organization (CRO)
  • Investigator Selection
  • Compensation to Subjects and Investigators
  • Notification/Submission to Regulatory Authority(ies)
  • Information on Investigational Product(s)
  • Manufacturing, Packaging, Labelling, Coding; Supply and Handling of Investigational Product(s)
  • Record Access
  • Safety Information and Adverse Drug Reaction Reporting
  • Monitoring and Monitoring Report
  • Quality Assurance and Quality Control, Audit
  • Noncompliance
  • Premature Termination or Suspension of a Trial
  • Clinical Trial/Study Reports

Investigator:

  • Investigator’s Qualifications and Agreements
  • Adequate Resources and Medical Care of Trial Subjects
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Investigational Product(s), Randomization Procedures and Unblinding
  • Informed Consent of Trial Subjects
  • Records and Reports
  • Progress Reports
  • Safety Reporting
  • Premature Termination or Suspension of a Trial
  • Final Report(s) by Investigator

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 4.30 PM)

 

1. IRB/IEC:

  • Safeguard the rights, safety, and well-being of all trial subjects (Special attention for trials involving vulnerable subjects)

2. The Monitor:

  • Trial monitoring and monitoring report

3. Clinical trial Protocol and amendments – Key components:

  • Objectives and Justification
  • Ethical Considerations
  • Trial design including Inclusion, Exclusion & Withdrawal of Subjects
  • Handling of the Product(s)
  • Statistics
  • Direct Access to Source Data/Documents
  • Data handling, management and record keeping
  • Quality Control and Quality Assurance

4. Essential documents required at various stages of a Clinical trial:

  • Before the Clinical Phase of the Trial Commences
  • During the Clinical Conduct of the Trial
  • After Completion or Termination of the Trial

5. Record Keeping and Data Handling, Reporting and archival

  • Documentation, Corrections, Electronic Data Processing, Validation of Electronic Data Processing Systems, Responsibility of Investigator/Sponsor and Monitor

6. Data integrity and compliance requirements

7. Recent Regulatory updates

8. GCP inspections and regulatory expectations

Q&A, Training Evaluation & GCP Training Certificate, Networking and Close: 3.30 PM – 4.30 PM

PRICING OPTIONS & REGISTRATION

 

VITS – Luxury Business Hotels

Andheri Kurla Road, International Airport Zone, Andheri (East), Mumbai 400 059, India

June 24 – 25, 2019

 





 





Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

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By accessing this website, you agree that Compliance Trainings will not be liable for any loss incurred due to the use of the information and the material contained in this website. The copyright in the material contained in the Website solely belongs to Compliance Trainings and any access to it by the general public does not imply free license to use it unless permitted by law.

 

Terms & Conditions to Register for the Seminar

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.

Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material, locations or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.





 


ASEPTIC PROCESSING WORKSHOP





 


WATER SYSTEMS WORKSHOP






 


GCP WORKSHOP






 


ASEPTIC PROCESSING, VALIDATION AND CHALLENGES