I, Syed Iftikhar Hussain Shah from ISLAMIC REPUBLIC OF PAKISTAN welcome you in the opening session of 03rd International conference on Pharmaceutics and NOVEL Drug Delivery Systems. I Feel both humbled and privileged addressing this session as a keynote speaker on behalf of honourable conference management.I believe that your presence and participation will certainly conclude some comprehensive and validated recommendations as per the theme of the conference.  I do believe, this event will approve some gold standards for the development of a novel community health system around the globe.We are here because we do realize an urgent need to upgrade and energize the provision of safe and effective research based medication for the treatment of challenging diseases in our specific regions and throughout the world on cumulative basis. We are the architects of medicine; responsible to execute the potent recipe, cost effectiveness, quality assurance and safe body compliance targeting the disease with an ideal mode of action.Very amicably I just want to present the following fields, if be considered in our discussions with the progress of this wonderful event: World pharma consultant forum -To design a charter  to identify the needs and address the relative perspectives and indicators for up gradation and sustainability of their existing legislations in local health care system.Motivation and internship training of young pharmacist groups to unite their energies for interactive education links, launching of campaigns to serve the ailing humanity, to improve their bilateral professional /managerial skills and cultural relations.World pharma Business forum can be introduced to avail the best possible offers/chances offered by the member countries in manufacturing, retails and marketing. Mutual retail pharmacy chains may be established within member countries.To launch a Common finance/ fund so as to support the victims of natural disasters round the globe, to award the fully /partially funded scholarships to talented and deserving graduates and post graduate levels.To establish regional consortiums for increasing the span of activities and more authentic feedback. To draft a viable plan to involve the pharmacists in PHARMACOGENOMICS, Use of SCREENING PROTOCOL, BIOLOGICS, PATIENT COUNSELLING and CLINICAL MANAGEMENT SKILLS.Enjoy this beautiful STAY in UAE where all the intellectual pharma brains around the globe have teamed up under one roof of this convention centre, with one aim to provide the safe cheap and effective medication for ailing humanity. No doubt, we are sincere enough. I request you all to utilize this quality time to conclude the event with an impact of deliverance. Life achievement conclusions will certainly make us proud for rest of our lives. Long live everybody. Be blessed and stay healthy. A big warm hug and Love from my side. May God help us with our aim.

Medical device is an instrument, appliance, apparatus, implement, machine, software, calibrator, contrivance, implant, Invitro reagent, or other similar or related article, along or in combination, including a component part, or accessory or other article intended for Diagnosis, Prevention, Monitoring, Treatment, Mitigation, Cure or Alleviation of disease, Investigation, replacement, or modification of the anatomy or of a physiological process. Supporting or sustaining life. Providing information for medical or diagnostic purposes by means of In-vitro examination of specimens derived from the human body. To affect the structure or any function of the body of man or other animals. A medical device should not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means. Medical device classification determinations should be based on a device’s potential to harm a patient, its intended use and also the technology it uses:

Manufacturers should document their justifications for assigning their devices to Class A, B, C or D. RAs should establish a device classification system consisting of four classes where Class A represents the lowest hazard, and Class D the highest hazard. Principle of medical device classification by GHTF through doc number GHTF/SG1/N77:2012 was developed and intended for use by RAs (Regulatory Authorities), CABs (Conformity & Assessment Bodies) and Industry. The actual classification of each device depends on the claims made by the manufacturer for its intended use and the technologies. As an aid to interpreting the purpose of each rule, illustrative examples of medical devices that should conform to the rule have been provided in the table of previous slide. However, it must be emphasized that a manufacturer of the medical device should NOT rely on its appearing as an example, but should instead make an independent decision on classification taking account of its particular design and intended use: Manufacturers of Class A devices should implement and maintain the basic elements of a QMS, but have the option of excluding design and development controls from it. The QMS is normally not subject to premarket on-site audit by the RA or CAB, except where assurance of sterility or of a measuring function is required. Manufacturers of Class B devices should implement and maintain an effective QMS, but may have the option of excluding design and development controls from it. Manufacturers of Class C and D devices should implement and maintain an effective QMS that includes design and development controls, and complies with GHTF SG3 guidance documents. For Class B, C, and D devices, the RA or CAB needs to have confidence that the manufacturer has an appropriate and effective QMS in place.

Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique  for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. It is a fast growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, high degree of automation, absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in pharmaceutical industry continue to grow and recent success of this technique has made it a useful tool of consideration as a drug delivery solution. The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. . HME involves the application of heat, pressure and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability.

The Pheroid® delivery system, a nano-based and micro-based transporter system, has been shown to have application in multiple sectors, including biopharmaceuticals, complementary medicines, cosmetics and agriculture.   These transporter systems can be used to alter the biological and behaviour of the molecules or compounds and hence the functional efficacy of these molecules or compounds in humans, animals, and plants. The scientific validation on the one hand and subsequent economically viable industrialization of such a platform technology on the other require different environments, expertise and functioning.  For the industrialization phase of the Pheroid® system, a Pheroid Cluster Incubator was established with the support of South African Department of Trade and Industry.  The Pheroid Cluster Incubator is a non-profit company consisting of 7 members that make use of the Pheroid® nano- and micro carriers in their products or are developing products containing the Pheroid® as shown in table 1.  The development stages and scientific validation of these products differ, as does the industrialization; benefits and pitfalls of product development within an incubator environment will be discussed.