Deadline concerns

Meanwhile the first tranche of the registration is done for all chemicals with a market volume of more than 1,000 Mg/a and for chemicals which have a high concern out of hazardous reasons (e.g., carcinogenic, mutagenic, or toxic to reproduction (CMR)). By the REACH deadline of 30 November 2010 for the first tranche, 24,675 registration dossiers were submitted for 4,300 substances including nearly... 

The first step is to identify existing substances, or particular uses of substances, that require authorisation, then to decide on deadlines for authorisation and any uses exempted from authorisation. As additional very high concern substances are identified, largely from testing for registration and evaluation, they will be fed into the authorisation system. 

In more recent years, in an attempt to overcome these problems, it has become fashionable to include more centres than what may be necessary in a study on the basis that some will be successful at recruiting whereas others will not. All, of course, have to be assessed to ensure that they can operate within the principles of GCP. It is important to be realistic in estimating the speed at which recruitment will occur and even in common disease areas, it is often unreasonable to expect centres to recruit at the rate of more than 1-2 patients per month. Nevertheless, the geographical distribution of clinical research is of major commercial concern because involvement of influential clinicians in the evaluation of a product is vital. It necessarily follows that involvement of influential clinicians in potentially large markets is of prime importance. Studies should, therefore, be conducted in these areas as first choice. However, this mandates willingness on behalf of the investigator to participate in pivotal studies and to meet development deadlines, which, of course, assumes the existence of an appropriate patient population and facilities for the conduct of the study. 

From then on, each CMS treats the application almost as a national application with the important differences that, first, they deal with the RMS (rather than the applicant) in respect of any concerns, queries or need for clarification, and secondly, the procedure is driven by predetermined immutable deadlines. 

Article 32 describes the timelines and the procedures to be followed following a referral. When reference is made to the procedure described in this Article, the CHMP has to consider the matter concerned and issue a reasoned opinion within 90 days of the date on which the matter was referred to it. However, in cases submitted to the CHMP in accordance with Articles 30 and 31, this period may be extended by 90 days. In case of urgency, on a proposal from its Chairman, the CHMP may agree to a shorter deadline. 

Sponsors set deadlines based on their individual needs. Vendors establish deadlines based on competing priorities and the needs of multiple customers. A sponsor s daily needs do not necessarily have an impact on the vendor s daily prioritization process. Sponsors tend to have the false perception that they are the only ones with a deadline. Vendors are managing deadlines for sometimes hundreds or thousands of clients. Knowing how the vendor manages the preparation, execution, and completion of the scope of work is an important tool for the sponsor. It can help the sponsor help the vendor by assuring that the appropriate issues are being discussed and dealt with at the appropriate time. It behooves the sponsor to become familiar with the vendor s overall operation and prioritization processes. This can only occur if the sponsor takes the time to listen and understand the supplier s concerns and capabilities. 

New substances will have to be registered before they can be placed on the market, with registration possible on or after June 1, 2008. Voluntary registration before the mandatory deadlines is possible on or after June 1, 2008. There are no fixed deadlines for Authorization (starting at Art. 55, list Annex XIV, based on criteria in Annex XIII). Specific deadlines will be fixed for each candidate substance, after a prioritization process. All SVHC will be subject to Authorization. These include chemicals that are level 1 or 2 CMR substances PBT substances vPvB substances or of equivalent concern (in particular having endocrine disruptive properties). Each Member State can also propose that other substances on the market be added to the candidate lists, via a complex process. 

The latter deadline is set nearly 20 years after the ministerial call for a new chemicals policy in the EU. Above 10 t, a Chemical Safety Report with data on a relatively large set of parameters, including data on intrinsic properties, exposure scenarios and risk management measures, is to be included in the registration (Article 14, Annex 1). For substances in quantities of 1-10 t, a technical dossier with more basic data (Article 10) is stated to be sufficient. Concerning so-called non-phase-in substances , i.e. basically those not being produced or marketed before REACH, the registration provisions entered into force on 1 June, 2008 (Article 141). 

Kilo lab batches Cost of raw materials may be fairly high. Invest time to decrease risk of poor yields. Meeting the deadline is primary concern. 

Toxicology batches (drug candidate) Meeting deadline is primary concern, to reach go/no go decision points during API development. Note that animals may be grown in advance of such studies. Invest time to determine and prepare desired final form (salt, polymorph). Prepare high-quality material, but not ultra-pure. If tox studies are conducted on material of an unrealistically high purity, subsequent tox studies will be needed to qualify batches of lower quality. 

Signature Requests These are messages concerning signature tasks and deadlines links to the corresponding records are automatically included. 

Timing concerning decision deadlines is also important for market research projects. Marketing information that is presented after a decision has been make is no good at all no matter how accurate and detailed it is. Marketing researchers should be well aware of the timing needs of the Marketing Department. 

I assume that this gap between theoretical chemists and chemical engineers exists because, until very recently, theoreticians had little to offer concerning the theory of fluids. However, during the past decade rapid progress has been made in this area and an attempt to bridge this gap now seems appropriate. This is an ambitious task and given the deadlines which are an unavoidable part of any conference, it is not a task that I would claim to accomplish fully here. However, I hope that this chapter will contribute to the bridging of this gap. 

Finding 2-lb. The task of destroying the very large qnantity of NSCWM at Pine Blnff Arsenal by 2007 is dannting, given that the planned non-stockpile facilities are not expected to be operational nntil 2006. As far as the committee can ascertain, the Army has not developed a timetable for destmction of this NSCWM that is both realistic and consistent with cnrrent treaty deadlines. The committee is concerned that withont clear planning and extraordinary efforts, the treaty deadlines will almost certainly not be met. 

At the same time, the Army must receive regulatory approvals from the states to handle and treat non-stockpile materiel, so it must address the regulatory concerns of the states. As indicated previously, these concerns have sometimes resulted in very significant delays in the RAP process (e.g., for the MMD-1 and the RRS). Regulatory delays may make attainment of treaty deadlines difficult. 

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