as of 10-Mar-04
Conference on Fixed-Dose Combination (FDC) Drug Products:
Scientific and Technical Issues related to Safety, Quality, and Effectiveness
29–30 March 2004
Gaborone, Botswana
Co-sponsors:
Joint United Nations Programme on HIV/AIDS (UNAIDS)
World Health Organization (WHO)
Southern African Development Community (SADC)
United States Department of Health and Human Services (HHS)
Background
Draft 3/7/04
Conference on
Fixed-Dose Combination (FDC)
Drug Products: Scientific and Technical Issues related to
Safety, Quality, and Effectiveness
March 29-30, 2004
Gaborone, Botswana
Cosponsors:
United States Department of Health and Human Services (HHS), the
World Health Organization (WHO), the
Joint United Nations Programme on HIV/AIDS (UNAIDS), and the
Southern African Development Community (SADC)
Background
HIV/AIDS, TB, and malaria are the foremost infectious disease threats to public health that the world faces today and are the focus of many global initiatives. Many consider combination therapy to be essential to the treatment of these diseases and to the prevention of drug resistance. An important approach to addressing the management of these diseases has included the development of fixed-- dose combinations (FDCs) of individual components administered together, as FDCs to simplify treatment regimens, improve patient adherence, and facilitate the implementation of interventional programs and prevent the development of drug resistance, and prevent the development of drug resistance. Notwithstanding the above, there willwill may be cases where individual drugs must be utilized for certain patients because of the challenges of dose titration, allergies to one or more of the components, different pharmacokinetic and/or pharmacodynamic profiles, and pharmaceutical development. The development of FDCs may vary depending on their individual active components and on the indication(s) that they target. Currently, there are no uniform principles, guidelines, or international standards addressing the development of FDCs and their potential benefits or possible disadvantages in treating these diseases.
Purpose of the Conference
Purpose of the Conference
The conference will discuss the draft Scientific and Technical Principles for Fixed-Dose Combination Drug Products (Principles Document) Points to Consider document developed by the Planning Group at its preparatory meeting in February 2004 in Cape Town, South Africa. During the opening session, presentations will place the draft Principles Ddocument in athe global context. Planning Group members will explain each of the various sections of the document and highlight areas on which comments would be especially helpful. The Conference participants will be asked by the Planning Group for feedback about specific sections of the documentoffer specific comments on the document and respond to questions from members of the Planning Group expert panels. [P. MIOTTI: THE PRECEDING SENTENCE IS NOT CLEAR ABOUT WHO DOES WHAT. I THINK IT IS BETTER TO STAY GENERAL AND SAY “ASKED FOR FEEDBACK BY THE PLANNING GROUP”] The conference-Planning Group will meet immediately following the conference on March 31 and make revisions to the draft document based on the conference deliberations. The conference co-sponsors plan to agree on the content of the final document within about approximately two weeks after the conference.
Purpose of the Document
Purpose of the Document
The Principles Ddocument focuses on aspects of the efficacy, safety, and quality of FDCs. The document is intended to provides points to consider when developing, evaluating, and/ or considering ccombination products for use in programs intended to that address optimum drug treatment combinations as fixed-dose drug combinations to facilitate the administration of drug regimens for the treatment of HIV/AIDS, tuberculosis, and malaria and their associated infectious diseases.s. It offers a set of principles that can be taken into account when considering FDCs, including planning for use in programs, development of and assessing assessment of FDCs. [P. MIOTTI: I DELETED THE SECTION ABOVE AS IT BASICALLY REPEATS THE SAME CONCEPTS
].
The document is not intended to be a therapeutic nor a regulatory guideline, and it will not address specific clinical or /non-clinical or clinical quality issues, or procurement and /distribution of specific products. The document will not deal with procurement per se and, treatment guidelines, patient adherence, or compliance with national regulatory requirements, or offer direct detailed regulatory guidance.
The co-sponsors and collaborators in this initiative expect that presenting a set of commonly agreed upon scientific and general principles, based on current knowledge, of quality, safety, and efficacy of FDCs to be used for the treatment of HIV/AIDS, tuberculosis, and malaria, based on current knowledge, will contribute substantially to international and national efforts to fight these diseases.
Who Should Attend?
Who should attend?
In addition to the co-sponsoring organizations and the PPlanning GGroup members, we expect participation by government officials from dDrug rRegulatory aAuthorities, public health leaders, health care providers, academia, procurement officials, the research-based and generic pharmaceutical industry, and non-governmental organizations—-- including patient groups, and international and regional organizations. The conference will be open to the public. Registration is limited to 150.
The conference will be held on Monday and Tuesday, 29-–30 March 2004, 09:00-–17:00 at the Gaborone Sun Hotel, Nyerere Drive North, Gaborone, Botswana,. Phone: (267)- 395-1111;
Fax: (267-) 390-2555. at the following times: Monday, 29 March 2004, 0900-1700 and Tuesday, 30 March 2004, 0900-1700
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