Adam Szpala is a professional trainer, auditor, and consultant with extensive international experience related to clinical trials. Here is some of his background:
Active participation in FDA and EMA inspections and pre-inspection activities in GCP, GLP and GMP areas;
Extensive working experience in highly regulated environment of GCP, GLP and GMP;
Experience in I-IV phases of clinical trials, ISO 9001 and Computer Systems Validation Since July 2009 conducted about 25 vendors and contractors audits including QC laboratories, Blood Sample Laboratories, licensing candidates, PK laboratories, safety and clinical laboratories, raw material manufacturers, IMP storage Facilities, IT suppliers;
Since March 2008 conducted 40 audits in GLP area (Vaccines, formulated proteins, monoclonal antibodies).
Since July 2009 conducted about 40 external audits in GCP area including:
Neurology, Pulmunology, Oncology, Cardiology, Primary Care, Medical Devices and Biologics (Vaccines, monoclonal antibodies)
Who should attend?
- Physicians interested in conducting clinical trials for cosmeceuticals;
- Professionals who have background in developing cosmeceuticals such as: Investigators, Research Nurses, Study Coordinators, Site Data Managers, CRAs, CTAs etc.
- People interested in career change opportunity
NB! Any person involved in selling, marketing, developing or exploring cosmetic
products. No previous experience is required.
Agenda:
Ethic, protection of volunteers, clinical studies, biomedical research, GCP,
evaluation of cosmetic safety
Regarding biomedical research used in cosmetic products, the Regulation (EC) No
1223/2009 of the European Parliament anticipates recommendations for good
practices. However, a large number of clinical cosmetics studies do not fall within the
scope of this law (non interventional studies). It is also vital that the rules of Good
Clinical Practices are applied for these studies in a cosmetics environment, to above
all protect the volunteer while guaranteeing the reliability of the data generated.
OBJECTIVES:
By using an original approach based on extensive feedback from experience, this
training course aims to satisfy the following objectives in the specific context of the
cosmetics industry:
- Understand the regulatory requirements in cosmetics relating to Good Clinical Practices (GCP), in a national and international context (or “Why and when GCPs must be implemented”).
- Understand the ethical requirements: definition of ethics, the underlying principle of clinical tests. What are the practical consequences? Learn ethical requirements at national and international levels. Learn how to protect the volunteer (health, protection of privacy (personal data, confidentiality) etc.)
- Understand the key functions in GCP organisation: The role of the investigator, promoter, monitor, in a cosmetics context.
- Learn how to set up a clinical study in the field of cosmetics and how to ensure that GCPs are complied with, that the data are efficiently collected, etc.
- Understand how to qualify a CRO in the context of GCPs in cosmetics and how to organise the quality assurance programme and quality control.
1. Introduction
- History of Good Clinical Practices (GCP)
- Definitions and genesis of this Quality reference framework: why use the GCP reference framework in the cosmetics industry?
2. Reference frameworks of regulations and standards
- Description of the regulatory and legislative environment in the cosmetics industry and in particular emphasis of the link with Good Clinical Practices (Directive on cosmetics, new European regulations, etc.). Overview of the main international regulations pertaining to this subject.
3. Ethical principles and protection of volunteers
- The basic concepts of ethics (Helsinki declaration, Nuremberg code, WHO, etc.). Once these concepts have been learned, GCP requirements become clearer.
- Impact on the measures to be implemented (Ethics Committee, how to draft an informed consent, confidentiality measures, protection of personal data, non inclusion criteria to conform to the rights of the volunteer, etc.)
4. Good Clinical Practices in the context of cosmetics
- The aim is to examine in detail and pragmatically what has to be set up in at a site of investigation carrying out clinical cosmetic studies so that they confirm to Good Clinical Practices adapted to cosmetics.
Organisation of a clinical cosmetic study
This entails describing “who does what and how”.
Monitor of the cosmetic study
- Qualification of the Monitor
- Qualification of the investigation site
- Management of the product investigation
- Drafting the protocol in collaboration with the investigator.
- Approval with participation in drawing up (if necessary) all the documents (informed consent, information sheet, CRF, etc.)
The investigator of the cosmetics study:
They are in charge of the overall management of the clinical study.
- Qualifications necessary
- Volunteer management (inclusion, medical examinations, monitoring/contacts, etc.).
- Management of products investigated.
- Management of documentation and records during the study.
- Management of resources used during the study.
- Management of UEs, SUEs. Reporting them in writing.
The Independent Ethical Committee
- Responsibilities and composition
- Operation and modalities specified in the procedures.
- Levels of intervention of IEC in the clinical cosmetics study.
Quality Assurance / Quality Control / Monitoring
- Quality Assurance approach and Monitoring / procedures to be implemented/ frequencies of audits/types of audits.
- Control of source data, CRF, respect of inclusion criteria, etc.
Data management
Guarantee the reliability of the data generated in paper or electronic form.
- Rules for archiving data to guarantee their integrity through time (durations of conservation, media/methods).
- Utilisation of computerised systems and validation principles.
This webinar will give you the following:
- Upon completion of the course each participant will be provided with a certificate of attendance ;
- A workshop at the end of the course which will give you time to ask questions and solve real-life practical case studies under the trainer’s guidance ;
- Access to training materials and useful information;
Course Duration:
Approximately 4-6 hours
