Good Clinical Laboratory Practice Workshop
(GCLP workshop)
Venue: Conference Room, AIIMS
Dates: 13th to 18th April 2009

Who should Attend it?
Middle and Junior level medical Microbiologists, Clinical Pathologists, Biochemists, Pharmacologists, Molecular Biologists, Internists, Pediatricians, Postgraduate in any medical pharmacy or nursing discipline, Laboratory Managers with postgraduate qualification and laboratory scientists processing samples for clinical trials.

How to Register?
The seats will be restricted to 50 only and participants will be registered on the first come-first served basis only.

Registration Fee:

Introduction:
Good laboratory practice regulations (GLP) became part of the regulatory landscape in the latter part of the seventies in response to malpractice in research and development (R&D) activities of pharmaceutical companies and contract facilities used by them. The malpractice included some cases of fraud, but by far the most important aspect of poor practice was the lack of proper management and organization of studies used to complete regulatory dossiers. The investigations of the US Food and Drug Administration (FDA) in the toxicology laboratories in the USA demonstrated a lack of organization and poor management which, it was decided, could only be dealt with by imposing regulations. These regulations are the GLP regulations. First the US FDA, then the US Environmental Protection Agency (EPA), instituted GLP regulations, and eventually many nations of the world followed suit.

GLP (OECD):
In 1981, the OECD also published GLP Principles and these have now dominated the international scene – so far 30 countries (the member states of the OECD) have signed agreements that make the OECD GLP Principles binding on them. This effectively makes the OECD Principles an international text.

The intent of GLP was to regulate the practices of scientists working on the safety testing of prospective drugs. With the obvious potential impact on consumers and patients recruited for clinical trials, the safety of drugs became a key issue and GLP was seen as a means of ensuring that scientists did not invent or manipulate safety data and a means of ensuring that GLP compliant studies are properly managed and conducted.

Hence GLP became the champion of the consumer, the regulatory safeguard, the guarantee that the safety data were being honestly reported to the registration or receiving authorities as the basis of a decision whether or not to allow a new drug onto the market. GLP was imposed on the industry by regulatory authorities, in the same way as good manufacturing practice (GMP) had been before, and good clinical practice (GCP) was to be afterwards.

GCP:
The history of Good Clinical Practice (GCP) statute traces back to one of the oldest enduring traditions in the history of medicine: The Hippocratic Oath. As the guiding ethical code it is primarily known for its edict to do no harm to the patient. However, the complexities of modern medicine research necessitate a more elaborate set of guidelines that address a Physician’s ethical and scientific responsibilities such as obtaining informed consent or disclosing risk while involved in biomedical research.

Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of biomedical data generated.

Most laboratories in the clinical research arena, however, do not fall under the oversight of any government regulatory authority. Often, in areas outside of Europe, Australia, and North America, there is no regulatory body devoted to laboratory science. In the areas where regulation exists, the targeted laboratories are either strictly “clinical” or “research” oriented. This type of scenario presents difficulties in discerning which regulations apply to laboratories engaging in clinical research.

GCLP:
GCLP is a relatively new approach to laboratory guidance which has been adopted by some European quality associations. The GCLP concept possesses a unique quality, as it embraces both the research/pre-clinical and clinical aspects of Good Laboratory Practices (GLP). It is becoming widely recognized that consistent GCLP application is paramount in the success of any clinical trial. In most cases, clinical trial data is largely laboratory in nature to include study endpoints and participant safety data. Hence, if this laboratory data is called into question due to inconsistent practices, an entire trial effort could be deemed as a failure. As a precautionary element, and to ensure the sponsor’s confidence in the good quality of data produced by any laboratory performing study testing, NIH has overseen the development of GCLP standards which encompass applicable portions of 21 Code of Federal Regulations (CFR) part 58, or GLP; and 42 CFR part 493, or the Clinical Laboratory Improvement Amendments (CLIA). These regulations were intended to ensure the quality and integrity of safety data, allow accurate reconstruction of experiments, allow for safe, quality products, and allow data to be comparable regardless of where generated. These guidelines also help assure sponsors and regulatory agencies that all data submitted are a true reflection of the results obtained during a study and that this data can be relied upon when making risk and/or safety assessments. Due to the ambiguity of some parts of these regulations, these GCLP standards also include guidance from other organizations and accrediting bodies, such as the College of American Pathologists (CAP) and The International Organization for Standardization (ISO), which better define the intent of GCLP that is presently undefined by a single regulatory body. By recognizing these standards as the minimum requirements for externally funded laboratory operations, the expectation is that GCLP compliance will ensure that consistent, reproducible, auditable, and reliable laboratory results that support clinical trials will be produced in an environment conducive to study reconstruction.

1. GCP and how it provides protection to study participants
2. GLP and how it ensures reliability of pre clinical toxicity data
3. Guidelines on Good Clinical Laboratory Practice: Bridging operations between research and clinical research laboratories.

Day 1
Inaugurations: Introduction to Principles of GLP

Day 2
GCP

Day 3
GCP

Day 4
GCLP

Day 5
GCLP, Valedictory function: Certificates to be distrusted by Dean, AIIMS