This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP). Participants will acquire real-world application of GCP regulations and guidelines for critical elements of the clinical research and development process. This training includes the updates brought by the ICH E6 R2 Addendum.
During this interactive workshop, we will debate in what way clinical research team members can apply systems to achieve data integrity and quality through the trial lifecycle.
Specific attention will be given to how quality systems affect overall data integrity, patient clinical risk, and respective regulatory risk.
Learning Objectives:
Learn how to:
- Describe the elements of functional Quality Systems for Sponsors, Institutional Review Boards (IRBs), and Clinical Investigators
- Identify the universal and local components of GCP
- Explain the differences between the legal and procedural elements of GCP
- Describe the overlap between GCP and Good Manufacturing Practice (GMP)
- Recognize key differences in pharmaceutical, device, and biologics GCP
- Examine recent trends in non-compliance
- Develop and implement site-specific approaches for corrective action of non-compliance
Areas Covered:
- Principles of GCP: Different Perspectives: Examination; application; implementation
- New Developments and Emerging Trends in GCP
- The “Forgotten” Elements of GCP: Regulations; laws; guidelines
- Quality Systems: The Roadmap to GCP: Quality control; quality assurance; quality improvement
- Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of protocols
- The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation; maintenance
- GCP Across Investigational Products: Drugs; devices; biologics
- Are We There Yet? Recent non-compliance issues with discussion of Corrective and Preventive Action planning
Who will Benefit:
This program is designed for professionals with two to three years of experience in the clinical research industry. Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP Focused Regulatory Affairs Professionals.
- 08.30 AM - 09.00 AM - Registration, Meet and Greet.
- 09.00 AM - Session Start Time
- Historical overview of Clinical Research
- Observational studies
- Case report
- Case series
- Cross section studies
- Case control studies
- Cohort studies
- Phases of Clinical Development & Types of Clinical Trials
- Planning and Initiating a Clinical Trial:
- Role of the Sponsor:
- Quality Assurance (QA) (see allocated time)
- Contract Research Organizations (CROs)
- Trial / Protocol Design
- Trial Conduct & Management
- Investigator Selection: Who can be an Investigator?
- Sponsor Monitoring (See allocated time below)
- Role of the Sponsor:
- Lunch Break
- Ethics & Research Subject Protection
- History of research ethics
- Human Subject protection
- Risk assessment
- Investigator Responsibilities:
- Qualifications & Agreements
- Resources & Selection of the trial team: delegation, Log of study Personnel, Keeping members informed
- Medical Care of trial subjects
- Compliance with the protocol
- Quality Assurance / Quality Control in Clinical Trials
- Defining the terminology
- The quality challenges
- The quality plan / Operational QC
- Role of Clinical Quality Assurance: What should you expect from Clinical Quality Assurance (CQA)?
- GCP Audits: what you need to know
- Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
- What is non-compliance?
- Most common inspection & audit findings
- Identifying the root cause
- Corrective Action versus Preventative Action
- What is NOT a good CAPA?
- Ethics for Genetics Research
- Informed Consent: The how? What? & why?
- Investigational Medicinal Product & Drug Accountability
- Safety Reporting:
- Protocol requirements pertaining to safety
- Expedited reporting of adverse events (AEs).
- What makes a well-documented adverse event (AE).
- What is a Suspected Unexpected Adverse Reaction (SUSAR).
- Laboratory Evaluations
- 09.00 AM - Session Start Time
- Drug Safety Monitoring Board (DSMB)/Independent Drug Monitoring Committee (IDMC) Clinical Trial Safety and Safety Monitoring
- Background & GCP Guidelines for DSMB/IDMC
- What are the processes of DSMB/IDMC Review?
- Sharing Best Practice in Patient Recruitment & Subject retention
- Subject Recruitment:
- Recruitment prediction,
- Advertising,
- Avoiding pitfalls.
- Lunch Break
- Essential Documents To Ensure A Complete TMF Under All Regulations
- Regulators’ Focus on TMF: Why?
- Why should sponsors Focus on TMF?
- Common Audit/Inspection TMF-related findings
- Lessons learnt………. Or…. Not!
- Data Quality and Archive
Amer Alghabban
Managing Director, GxP Compliance and Training Partners (GCTP)
Amer Alghabban, M.Sc. (Clin. Pharmacology), Post-Grad. Cert. Clinical Research, Dipl. Bio. Sci., B.Sc., Cert. Teacher Education, M Soc. Pharm. Med., MRQA, MIQA, MDIA, ISO 9001:2015 QMS Certified Lead Auditor, IRCA Certified Lead Auditor.
Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP), which he founded, helping pharmaceutical companies & academic institutions worldwide to achieve compliance with GCP, GVP, GCLP, GDP and GLP.
Amer, a Clinical pharmacologist by education, has over 28 years’ experience in the pharmaceutical industry. He enjoys imparting his experiences, as an invited speaker at over 125 international congresses and as writer; he published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Amer has experience of working at the MHRA where he participated in the conduct of the very first Regulatory Authority pharmacovigilance-GCP inspection in the EU and wrote the 1st EU regulatory authority SOPs on conducting GVP inspections. He has over 21 years’ experience of directing Inspection Readiness Programs (Mock Inspections & Pre- & Post-Mock Inspection-Training) and hosting regulatory authorities’ & notified bodies’ inspections. To date, he has prepared, trained, hosted & managed over 67 Regulatory Authorities’ inspections by all major regulatory authorities (FDA, EMA, EU Authorities (CAs), Japanese PMDA, Brazilian, Chinese SFDA & Middle Eastern authorities etc.) Earlier in his career, he was Assistant Editor for 11 medical journals and was the 1st invited Course Director for The Pharmacovigilance Auditing Course at the RQA.
Amer’s other previous positions included: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. Boston, USA, Global Director, Head of Quality Assurance at Merck Serono, Geneva, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
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 @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656
Media Partner:
Hospitals-Management is essentially a B2B online business and media platform that has under it wraps the largest global database of Healthcare buyers and suppliers. Hospitals-Management.com covers in-depth trends that shape industry dynamics and metamorphose global economics.
Local Attractions of Zurich, Switzerland
Kunsthaus Zurich
The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.
Bahnhofstrasse
Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.
Zurich Zoo
Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.
Limmat River
Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.
Fraumunster Church
The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.
Zurich Old Town
Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings
