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%.
- Regulatory Affairs
- Regulatory & Pharmacovigilance
- Clinical Affairs & Regulatory Strategies
- Regulatory Cooperation and Reliance
- Pharmaceutical Regulatory Environment
- Regulation and Global Regulatory Affairs
- Biologics and Biosimilars
- Best Industry Practices
- Intellectual Property Rights
- Marketing Authorizations-Affordable Healthcare and Fair Trade
- Medical Device & Combination Products Regulations
- Regulatory Strategies and Developments
- Regulatory Requirements for Pharmaceuticals
- Entrepreneurs Investment Meet
- 300+ Participation (70 Industry: 30 Academia)
- 5+ Keynote Speakers
- 50+ Plenary Speakers
- 20+ Exhibitors
- 14 Innovative Educational Sessions
- 5+ Workshops
- B2B Meetings
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.
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.
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.
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
- Partnering / Alliance Management
- Regulatory Affairs
- Lifecycle Management
- External Manufacturing