6^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sept 29-30, 2016 Orlando, USA

ConferenceSeries Ltd invites all the participants from all over the world to attend '6^th  Conference and Exhibition on Regulatory Affairs and IPR' during Sep 29 - 30, 2016 in Orlando, USA which includes prompt keynote presentations, Oral talks, Poster presentations and Exhibitions.  

Regulatory Affairs department is the strength of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies. More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. ConferenceSeries Ltd organizes a series of 1000+ Global Events inclusive of 600+ Conferences, 500+ Upcoming and Previous Symposiums and Workshops in USA, Europe & Asia with support from 1000 more scientific societies and publishes 700+ Open access journals which contains over 30000 eminent personalities, reputed scientists as editorial board members. 

Track 1: Regulatory Affairs

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products. The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical industry. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. 

Related Conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 2:  Regulatory and Pharmacovigilance

Regulatory affairs (RA), also called government affairs, are a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:

Working with federal, state and local regulatory agencies and personnel on specific issues affecting their business i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e., describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 3: Clinical Affairs & Regulatory Strategies

A regulatory-science driven regulatory strategy is essential as part of today’s biopharmaceutical product early development planning.  A well-prepared regulatory strategy will align the proposed clinical development plan with business objectives, and pre-emptively identify challenges, as well as, proposed alternative/innovative approaches to new product development which leverage new standards for evidence generation supporting continuing development and global market authorization. A regulatory strategy helps to define key issues/challenges to proactively discuss with Regulatory authorities and also defines key program milestones that are often considered business catalysts driving investor interest and financing.  Most importantly, a timely, well-prepared and well-maintained regulatory strategy, with proactive and collaborative interaction with regulatory authorities, is often a differentiating factor for industry leaders bringing commercially successful and innovative products to market in today’s competitive marketplace. Regulatory strategy is a major component of successful biopharmaceutical product development.  Covance Global Regulatory Affairs prepares and maintains regulatory-science driven and product-specific global regulatory strategies for many product types, e.g., drugs, biologics, drug-device combinations, vaccines, gene-therapies, cell-therapies, across a range of therapeutic areas and full regulatory strategy support for product development initiatives.

Related Conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 4: Regulatory Cooperation and Reliance

The novel regulatory aspects include Novel Drug Delivery Systems, Medical Affairs, Active Pharmaceutical Ingredients, and Licensing in pharmaceutical production, packaging materials and pharmaceutical excipients. The new setting is testing the resilience and ingenuity of company corporations across the world. Some business models lack the ability to survive the approaching finish of the “blockbuster drug” era, even whereas resource constraints and sluggish innovation hinder the event of recent capabilities required to thrive in a very apace evolving market. These square measure so tumultuous times for the U.S. company trade. Succeeding in a very shifting world market and evolving tending landscape would require pharmaceutical corporations to adopt innovative business models targeted on novel ways, including: stress on “economic” outcomes: additional attention to the “economic value” of a medical care as a determinant for analysis funding and development. Personalised medicine: Shifting from “blockbuster drugs” to “personalized health and wellbeing.” Externalization and collaboration: additional reliance on external partners, academia, trade consortia and entrepreneurs for innovation, productivity and world growth. Globalization: fast growth to for countries for scientific talent and new markets. Health IT adoption: finance in new technologies to modify innovation and drive efficiencies. Novel Regulatory strategies include both Nano therapeutics and biotech therapeutics.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 5: Pharmaceutical Regulatory Environment

Guidelines on clinical trials for import and manufacture of new drug were introduced in the Drugs and Cosmetics Rules as Schedule Y in 1998. This heralded the entry of clinical trials organization like Quintiles into India and encouraged the pharmaceutical industry to conduct phase III trials. Ethical Guidelines for Biomedical Research on Human subjects was brought by Indian Council of Medical Research (ICMR) in 2000. Good Clinical Practices were adopted by India in 2001 by Central Drugs Standard Control Organization (CDSCO). The National Institute of Medical Statistics of ICMR also set up a clinical trails registry in 2009. A new amendment to the Drugs & Cosmetics Act is seeking to replace the Central Drugs & Services Control Organization (CDSCO) with the Central Drug Authority (CDA) comprising of Drugs Controller General of India as the chairman and five other members. Ten departments will be controlled by the authority include regulatory affairs, imports, new drugs, biotech products, Pharmacovigilance, medical devices and diagnostics, organizational services, training, quality control and legal & consumer affairs. Moreover new bill for regulation of medical devices industry is also in the gambit. Medical Devices Regulatory authority is a body; government is yet to implement to regulate the ballooning medical devices industry whose products are largely approved in other countries and eventually finds entry into Indian market.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).        

Track 6: Regulation and Global Regulatory Affairs  

The regulatory landscape has continued to evolve in response to product safety, regulatory compliance, new technologies, improved understanding of disease states, stakeholder and customer needs and global imperatives, with new and increasing regulations, regulatory guidance and oversight. The Global regulatory affairs group and the regulatory professionals in the biopharmaceutical industry occupy a central and pivotal role to all the functional groups. The regulatory team is charged with a strong leadership role that ensures compliance with regulations and enables understanding and interpretation of the dynamic regulatory landscape, while creating opportunities in the highly-regulated and complex environment. The challenging landscape is largely a result of the success of the biopharmaceutical industry in delivering medical therapies for many disease states, safety catastrophes from use of products post-approval; and product quality compliance issues. These have sharpened regulatory authorities focus on product benefit/risk profiles and related stakeholders’ views on cost effectiveness and patient access. The regulatory professional has to be equipped and poised to effectively guide the organization to success with a credible voice, informed strategic guidance and objective evaluation.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 7- Biologics and Biosimilars

A biopharmaceutical, also known as a biologic medical product or biologic, is any medicinal product manufactured in, extracted from, or semi synthesized from biological sources. Different from chemically synthesized pharmaceuticals, they include vaccines, blood, or blood components, allergenic, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They are isolated from natural sources—human, animal, or microorganism. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid–based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).    

Track 8: Best Industry Practices

Drug business is one in every of the country’s most significant economic engines, commerce $15 billion in merchandise annually and a few of its factories area unit foremost. The federal agency has developed a series of tips for developing GXP (which includes GCP, GLP and GMP regulations) that shield each the life sciences business and also the customers they serve. So as to help FDA-regulated firms, master control offers associate in integrated quality and compliance management code that assures GLP, GCP and GMP rules compliance. Industry practices is also part of quality risk management system, Pharma Regulatory Affairs, Audits and inspections, validation methods (process validation and analytical validation), Qualification, validation, calibration, maintenance, risk analysis Drug Safety and Good Pharmacovigilance practices. A number of our software system applications which will facilitate with GLP GCP GMP rules embody the subsequent solutions: Document Control/ Document Management, Corrective Action Preventive Action (CAPA), modification management, coaching Management, nonconformity Automation software system, Audit Management in step with GLP GCP GMP rules, client complaints software system, forms-based method automation, electronic submissions.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).     

Track 9: Intellectual Property Rights

In the EU, a biological meditative product is one amongst the active substance(s) created from or extracted from a biological (living) system, and needs, additionally to physico-chemical testing, biological testing for full characterisation. The characterisation of a biological medicative product could be a combination of testing the active substance and therefore the final medicative product at the side of the assembly method and its management. Principal ideas of Intellectual Property Management (IPM) and its importance is a spur to human power and therefore is the advancement of economic and social development. It additionally provides rationalization on the event Associate in implementation of an IPM strategy together with the management of material possession (IP) in an internet setting. Scientific discipline law usually grants the author of associate in intellectual creation exclusive rights for exploiting and cashing in on their creation. Scientific discipline protection is meant to stimulate the power of the human mind for the advantage of all by making certain that profits derived from exploiting a creation benefit the creator. This may encourage activity and permit investors in analysis and development a good come on their investment. Scientific discipline confers on people, enterprises or alternative entities the correct to exclude others from the employment of their creations safety and quality regulation in labelling. Consequently, material possession rights (IPRs) could have an on the spot Associate in substantial impact on trade because the owner of an IPR could - through the social control of such a right - forestall the manufacture, use or sale of a product which includes the IPR. For this reason management over the intangible (IPR) connotes management of the merchandise and markets. Scientific discipline protection encourages the publication, distribution and speech act of the creation to the general public, instead of keeping it secret whereas at identical time encouraging industrial enterprises to pick out inventive works for exploitation. Material possession legal titles relates to the acquisition and use of a variety of rights covering completely different form of creations. Patents in the pharmaceutical industry include both legal and ethical issues.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 10: Marketing Authorisations-Affordable Healthcare and Fair Trade

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. Global regulatory affairs groups in industry provide worldwide, strategic leadership in and comprehensive direction of the government regulatory requirements for product introduction and commercialization, utilizing regulatory knowledge to ensure compliance and regulatory intelligence and create opportunities in a highly-regulated environment. The global regulatory affairs group has strategic and operational functions, requiring precision and flawless execution, as a company’s success relies on, in part, the guidance and rigorous assessment provided by the regulatory affairs team. The key product development, manufacturing and registration milestones (such as Investigational New Drug filing, end of phase II, phase III, New Drug Application submissions, regulatory agency review timetable and product approvals), which are the corporate valuation and decision points, are based on critical regulatory interface goalposts and milestones. This underscores the importance of strategic regulatory contribution to the industry. In order to be valuable contributors and critical business partners, the global regulatory affairs organization must develop mechanisms and establish systems to ensure it has the right people and talent, proficient processes, prolific productivity, phenomenal performance and precision in planning.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 11: Medical Devices & Combination Products Regulation

FDA laws and rules needed to with success develop and commercially market medical devices within the US. Topics include: product development/approval method, post-market controls, state and federal website inspections, social control activities, and suggestions for operating proactively with the authority. The term medical devices or Medical Devices Regulatory Affairs covers an enormous varies of kit, from straightforward tongue depressors to haemodialysis machines. Like medicines and different health technologies, they're essential for patient care – at the side, at the agricultural health clinic or at the massive, specialised hospital. Makers should list their devices with the authority. Institutions needed to list their devices include: makers, contract makers that commercially distribute the device, contract sterilizers that commercially distribute the device, repackages, Medical device reporting and re-labellers, specification developers, reprocesses single-use devices, remanufacturer, makers of accessories and parts oversubscribed on to the top user, U.S. makers of "export only" devices. Medical device rules includes: Medical device reportage, Governmental regulation of medical devices, world Harmonization Task Force (GHTF), optimizing the utilization of Pharmaceutical Regulatory Affairs.

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 12: Regulatory Strategies and Development

Most regulatory professionals focus their careers on the regulations of a single country or region such as the US or EU. In order for a global regulatory leader to be truly effective, it is critical to understand the key regulatory issues in all major markets and to apply this knowledge to a global regulatory strategy. Communication between health authorities is increasing, making it vitally important that regulatory leaders develop their strategies with a global view. In addition, current trends in the pharmaceutical industry indicate that more and more companies are expanding their global presence to benefit from the explosive growth being projected in the emerging markets. This course will allow participants to understand key requirements for the development and execution of a global regulatory strategy by identifying the strategic and tactical aspects of pharmaceutical development in the US, EU and emerging markets.  Course participants will have the opportunity to apply learning objectives in a hands-on workshop

Related conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).

Track 13: Regulatory Requirements for Pharmaceuticals

The area unit variety of motives for extending the merchandise development outside of the mature, developed economies (e.g. the EU and therefore the US) and most of them have faith in the high population and market potential of rising markets. FDA guidance for clinical investigations and Pharmaceutical development goes a lot of and a lot of  within the direction of rising markets that tend to supply solutions for the patient achievement and overall development prices and timelines. Some reasons for this growing trend area unit result of the inevitable “patent cliff” that forces firms to any extend their reach and develop any. It's clear that rising markets supply nice market and population potential however at constant time cause sure challenges, as well as moral, GCP. Licensing in pharmaceutical production is mandatory step for pharmaceutical products. Regulatory matters is definitely acknowledged by the complete pharmaceutical community and authorities try to develop a cooperative model for harmonizing the Regulatory necessities across the regions so as to ease the world pharmaceutical development (Active Pharmaceutical Ingredients, Pharmaceutical excipients and Packaging materials) and acceptance of knowledge. Having a neighbourhood experience will highlight these challenges and necessities which might facilitate decide however  the corporate extremely desires to travel. Generally the proper Regulatory info at the proper time may be a crucial issue for reaching proper choices since it looks that pharmaceutical firms have chance to decide on their development direction however no chance to bypass the need for selection

Related Conferences:

Global Pharmaceutical Industry Summit August 22-24, 2016 Vienna, Austria; 2^nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5^th Summit on Good Manufacturing Practices, GCP and Quality Control August 12-13, 2016 Toronto, Canada, USA;  Conference on Generic Drug Market Nov 07-09, 2016 Barcelona, Spain; Conference on Contract Manufacturing Nov 07-09, 2016 Barcelona, Spain; RAPS Regulatory Convergence September 17-20, 2016 CA, USA; 9^th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15^th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2^nd Annual Pharma Market Asia  August 02-06, 2016 Suntec, Singapore;  Pharmaceutical Compliance Asia August 02-06, 2016 Suntec, Singapore. Regulatory Affairs Professional Society (RAPS), The Center for Professional Advancement (CfPA), The Canadian Association of Professionals in Regulatory Affairs (CAPRA), American Chemical Society, The Organisation for Professionals In Regulatory Affairs (TOPRA).