Theme: Novel Regulatory Environments and Requirements

Regulatory Affairs 2016

Regulatory Affairs 2016

Conference Series LLC invites all the participants from all over the world to attend '6th  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. Conference Series LLC 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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, Pharmacovigilancemedical 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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; 2nd Separation Techniques Conference September 26-28, 2016 Valencia, Spain; Conference on Pharma Marketing November 10-11, 2016 Alicante, Spain; 5th 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; 9th Annual Pharmaceutical Regulatory Affairs Asia August 02-06, 2016 Suntec, Singapore; 15th EGA Regulatory and Scientific Affairs Conference  28-29, January 2016 London, UK; 2nd 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).

 

Conference Series LLC is a renowned organization that organizes highly notable pharmaceutical conferences throughout the globe. After a successful conference of RegulatoryAffairs 2015, Conference Series LLC is currently bringing forth "6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs & IPR” (Regulatory Affairs 2016) slated on September 29-30, 2016 at Orlando, USA.

Conference Series LLC invites all the participants across the globe to attend the "6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs & IPR (Regulatory Affairs 2016) slated on September 29-30, 2016 at Orlando, USA. Regulatory Affairs 2016 provides the perfect one-stop resource with the information and knowledge resources to help you develop skills and learn proven strategies and techniques to help you overcome the challenges you face in the Regulatory profession.

  • The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%.
  • Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%
  • The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

2016 Highlights:

  • 300+ Participation (70 Industry: 30 Academia)
  • 5+ Keynote Speakers
  • 50+ Plenary Speakers
  • 20+ Exhibitors
  • 14 Innovative Educational Sessions
  • 5+ Workshops
  • B2B Meetings

Why Should I Attend?

  • Novel approaches about the drug delivery systems development and industrializing insights & gain the latest technologies about novel drug delivery systems and applications
  • Meeting with 50+ industrial experts, 50+ academic speakers, 50+Pharmaceutical Companies, 120+decision-makers interacting
  • Finding novel opportunities of doing NDDS business and dynamically providing the “value addition” to pharmaceutical R&D businesses
  • Bridging the gap between Academia and Industry in novel research methods of DDS
  • Emphasis on novel strategies for formulation and drug delivery system’s latest updates to drive your market share accordingly
  • Learn on the applications of novel DDS for treating major diseases to progress the drug portfolio industrialization pathways

Who Should Attend?

Pharmaceutical, biotech, CRO, diagnostic and academic professionals specializing in:

  • Drug Delivery
  • Product Development
  • Formulation / Pre-Formulation
  • Structure and Informatics
  • Pharmaceutical Development
  • Technology Assessment
  • PK / PD
  • Medicinal Chemistry
  • Licensing
  • Outsourcing
  • Partnering / Alliance Management
  • Regulatory Affairs
  • Lifecycle Management
  • External Manufacturing

Summary:
Regulatory Affairs Professionals Society (RAPS) Professional Development Framework (PD Framework) for the healthcare product regulatory affairs (RA) profession. The PD Framework offers a model for describing the basic body of knowledge and relevant skills of the RA profession across product lines, geographic locations and employer types at four major career stages. The framework is the result of years of research and development carried out by RAPS with the involvement of members worldwide. The studies’ results provide valuable insights into the nature of the profession. The framework defines the profession by professional/career levels, domains that reflect steps in the healthcare product lifecycle, the responsibilities and tasks of the RA professional at each step and the associated core knowledge and skills required of the professional.

Importance & Scope:

Regulatory Affairs is a 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, cosmetics.

Regulatory Affairs importance is to provide the strategic regulatory framework for the submission, to advise on procedures and formats, to collect, evaluate and compile the scientific data and information on the product. Conference share knowledge to the Pharma Industry Professionals, Professors and Students. Both Pharma companies and Bulk drug industries can be involved.

The regulation of medical products has been expanding since early 20th century. Regulatory agencies are being established in an ever increasing number of countries across the globe. Those that have established are reorganizing their systems and attempting to harmonize with organizations of other countries. The pharmaceutical, biotechnology and medical devices are among the most highly regulated industries in the world.

Why Florida?

After years of aggressive, coordinated effort, Florida has firmly established itself as a true hub for the Pharma industries. Today, Florida is home to some of the nation's most highly regarded research centers; over 1,000 biotech, pharmaceutical and medical devices companies; industry leaders - including Actavis, Arthrex, Bristol Meyers Squibb, Johnson & Johnson, Medtronic, Noven, and Steripak.

Florida’s 200+ pharmaceutical and medicine manufacturing companies specialize in the development and manufacture of novel treatments, generics, nutraceuticals and OTC drugs. They employ nearly 4,500 researchers, engineers, technicians and workers.

Florida boasts the 2 largest medical device manufacturing industry in the U.S. Nearly 19,000 Floridians work in this industry, with a majority of companies located along the I-4 Corridor in Central Florida, the Jacksonville area, and in South Florida. Florida is home to more than 250 biotech companies and world renowned R&D institutes specializing in therapeutics, diagnostics, industrial/ag biotech and other areas. Florida has the science, talent, and support structure biotechs need to succeed.

Conference Highlights:

  • Regulatory Affairs
  • Fundamentals of Regulatory Affairs
  • Clinical Regulatory Strategies
  • Novel Strategies for Growth in the Pharma and Regulatory Affairs
  • Pharmaceutical Regulatory Environment
  • Regulation and the Global Regulatory Affairs
  • Biologics and Other Products
  • Best Industry Practices
  • Interllectual Property Rights
  • Marketing Authorizations, Advertising and Marketing Practices
  • Requirements for Medical Devices
  • Regulatory Strategies and Developments
  • Regulatory Requirements for Pharmaceuticals

Why to attend??

A deep understanding of legal, ethical and policy context is required to effectively navigate through today's regulatory environment. The Florida focuses in pharmacy with concentration in Pharmaceutical Outcomes & Policy to enable regulatory professionals, as well as health systems and insurance administrators, pharmacists, and lawyers to effectively create, manufacture and deliver pharmaceuticals that are safe for patient use and meet the policy and laws in place.

Major Associations in Florida

  • Florida Society of Health-System Pharmacists
  • Central Florida Pharmacy Association
  • FPA - Florida Pharmacy Association
  • Escambia County Pharmacy Association
  • National Alliance of State Pharmacy Associations
  • Dade County Pharmacy Association
  • The Asia-Pacific Professional Services Marketing Association (APSMA)
  • Association of Internet Marketing and Sales (AIMS)-Canada

Major Associations in USA

  • Regulatory Affairs Professionals Society
  • Regulatory Affairs-American Chemical Society
  • TOPRA-The Organization for Professionals in Regulatory Affairs
  • Orange County Regulatory Affairs Discussion Group (OCRA)
  • The Canadian Association of Professionals in Regulatory Affairs (CAPRA)
  • AAPS Regulatory Affairs
  • American Bakers Association
  • American Association of meat processors
  • American Herbal Products Association (AHPA)

Statistical Analysis of Associations

Target Audience:

Directors/Managers & Business Intelligence Experts, Departmental Managers, Vice Presidents/ Directors, Pharmaceutical Scientist, Scientist, Policy Analyst, Pharmaceutical Companies, Bulk drug Industries, Pharmaceutical regulatory agencies, Professors and Students from Academia in the study of Pharmaceutical  regulatory affairs.

Top Universities in Florida:

  • Nova Southeastern University - College of Pharmacy
  • University of Florida College of Pharmacy
  • University of South Florida - College of Pharmacy
  • Lake Erie College of Pharmacy
  • Palm Beach Atlantic University - School of Pharmacy

Figure 2: Statistical Analysis of universities in Florida, USA and World wide

 

Companies Associated with Regulatory Affairs

Figure 3:  Companies Associated with Regulatory Affairs in Florida, USA and World wide

Marketing Analysis for Drug Approval:

Regulatory Affairs Department is the backbone 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. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400 As per cabinet decision in June 2010 in Japan amended a new policy i.e., Health power strategy through “Life Innovation” and expenditure spent on each drug was $450 million .

Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities. Industrialized regulatory affairs is to drive compliance, speed to market, and cost efficiency.

Statistics which shows Expenditure spent on each drug for approval global, USA & Florida

Figure 4: Expenditure spent on each drug for approval Florida, USA & global

 

Figure 5: Expenditure spent on each drug country wise for drug approval

Regulatory Affairs 2015

Conferenceseries LLC 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs at Orlando, Florida, USA during August 03-05, 2015 was organized with a focus on “Share and Enhance the Aspects on Novel Policies in Regulatory Affairs” was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering.

Regulatory Affairs 2015 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various newfangled topics related to the field of Pharma and Regulatory Affairs.

Conferenceseries LLC would like to convey a warm gratitude to all the Honorable guests and Keynote Speakers of Regulatory Affairs 2015:

  • Ting-Chao Chou, PD Science LLC, USA
  • James J Hickman, University of Central Florida, USA
  • Michael Drues, Vascular Sciences, USA
  • Kishor K Chakraborty, Riyadh Pharma, Saudi Arabia

Regulatory Affairs 2015 Organizing Committee would like to thank the Moderator of the conference and all other attendees who contributed a lot for the smooth functioning of the event

Conferenceseries LLC also took the privilege of felicitating Regulatory Affairs 2015 Organizing Committee, Keynote Speakers, Chair and Co-Chairs whose support made conference a great success.

5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs was a great success with the support of International multi professional steering committee and coordinated by the Pharmaceutical Regulatory Affairs: Open AccessJournal of Bioanalysis & Biomedicine and Advances in Pharmacoepidemiology & Drug Safety.

With the enormous feedback from the participants and supporters of Regulatory Affairs 2015, Conferenceseries LLC Conferences is glad to announce 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sep 29- Oct 01, Orlando, USA.


Past Reports  Gallery  

Regulatory Affairs-2014

Conferenceseries LLC's  4th International Conference on Pharmaceutical Regulatory Affairs at  DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA during September 08-10, 2014 was organized with a focus on Key implications in Regulatory environment was a great success where eminent keynote speakers from various reputed institutions made their resplendent presence and addressed the gathering.

Regulatory Affairs-2014 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various newfangled topics related to the field of Pharma sectors.

Regulatory Affairs-2014 Organizing Committee would like to thank the Moderator of the conference, Ms. Mariam Aslam, ESCOP, UK who contributed a lot for the smooth functioning of this event.

OMICS Group International would like to convey a warm gratitude to all the Honorable guests of Regulatory Affairs -2014:

  • Jerry Xu, WuXi Apptec, China.
  • David Hawley, IS Compliance and Validation, North America
  • Michael Drues, Vascular Sciences, USA
  • Donald MinUnited States Pharmacopeial Convention, USA

The highlights of the conference were its educative and effectual keynote lectures by:

  • Adam Sabouni, PharmaConsultz, USA
  • David Hawley, IS Compliance and Validation, North America
  • Michael Drues, Vascular Sciences, USA
  • Jerry Xu, WuXi Apptec, China

OMICS Group, on behalf of the conference, congratulates the Best Poster awardees for their outstanding performance in the field of  Regulatory Affairs and appreciates all the participants who put their efforts in poster presentations and sincerely wishes them success in future endeavours. We would like to thank the Poster Competition Judge Dr. David Hawley, IS Compliance and Validation, North Americafor his valuable time.

Best Poster Winners:

  • Krasimira Pekova, Artisan Healthcare Consulting, Inc., USA
  • Varley Dias Sousa, University of Brasilia, Brazil

OMICS Group also took the privilege of felicitating Regulatory Affairs-2014 Organizing CommitteeEditorial Board Members of Pharmaceutical Regulatory Affairs: Open AccessJournal of Bioanalysis & Biomedicine  &  Advances in Pharmacoepidemiology & Drug Safety, Keynote Speakers, Chair and Co-Chairs and Moderator whose support made conference a great success.

With the enormous feedback from the participants and supporters of Regulatory Affairs-2014, OMICS Group Conferences is glad to announce its 5th International Conference on Pharmaceutical Regulatory Affairs (Regulatory Affairs-2015) from Aug 3-5, 2015 at Florida, USA with the theme Current Research & Advancements in Pharmaceutical Regulatory Affairs”.


Past Reports  Gallery  

Regulatory Affairs-2013

3rd International Conference on Pharmaceutical Regulatory Affairs was held during October 21-23, 2013, at San Francisco, USA with a theme “Embracing Recent Strategies in Global Regulatory Affairs” brought together the International blend of people from regulatory affairs industry making it the largest endeavour from Conferenceseries LLC. All the papers presented at this conference were published in special issue of Pharmaceutical Regulatory Affairs: Open Access.

Regulatory Affairs-2013 opened up new vistas and fostered collaborations in the industry and academia.

The conference was embarked with an opening ceremony followed by a series of lectures delivered by both Honorable Guests and members of the Keynote forum. The adepts who promulgated the theme with their exquisite talk were;

Mohammed R Khan, Synergex Consulting, Canada
Steve Jwanouskos, OptiMedica, USA
Chitra Edwin, Cleveland HeartLab, Inc., USA
Rama K Pidaparti, Wipro Technologies, USA

Conferenceseries LLC has taken the privilege of felicitating Regulatory Affairs-2013 Organizing Committee, Keynote Speakers and business delegates who supported for the success of this event.

Conferenceseries LLC, on behalf of the conference, congratulates the Best Poster awardees for their outstanding performance in the field of pharma regulatory affairs and appreciates all the participants who put their efforts in poster presentations and sincerely wishes them success in future endeavours. Our warm gratitude to our sponsors, exhibitors & media partners for associating with the conference.

Following on the heels of this successful event we are excited to announce 4th International Conference on Pharmaceutical Regulatory Affairs to be held during September 08-10, 2014 at Raleigh, USA with a theme “Key Implications in Regulatory Environment” and wish that with your overwhelming support for Regulatory Affairs-2013 will become an outstanding event.


Past Reports  Gallery  

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