Know your regulators: Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development

Instructor: Prasad Panzade

As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country. In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.

USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory agencies and organizations established in respective countries. In this presentation a detail emphasis will be projected on what are the various requirements and how the audits are performed by the respective regulatory agency with case studies and audit examples.

Medicines that are of adequate quality, are safe and efficient are required. Health care professionals and patients must have the needed information to enable them to use the medications rationally. Medicines must be manufactured, stored, distributed and dispensed in appropriate manners. Any illegal manufacture and trade of drugs must be both detected and adequately sanctioned. Promotion and advertising of drugs must be balanced, fair and aimed at the rational use of drugs. Access to medications must not be hindered by unjustified regulatory work. Effective drug regulation on the part of nations both promotes and protects the health of the public through ensuring several things.

National governments are held responsible for the establishment for strong national drug regulation authorities (DRA's)that have a clear mission, realistic objectives, a solid legal basis, an appropriate organizational structure, suitable financing, an appropriate level of qualified staff, equipment and information, access to technical literature, and the capacity to exert effective market control. DRA's are accountable to both the government and the public at large for their decisions and should be transparent. The DRA's evaluation and monitoring mechanisms need to be built into its regulatory system to assess attainment of its established objectives.

Why Should you Attend:
To have a better handle and understandings of requirements and regulations in regards to filing, inspections and preparations of documents. This webinar will also provide some real-time examples during audits from the past and the impact on those organizations. During this webinar various ways of DMF filing will be discussed.

Objectives of the Presentation:
Drug master filing preparation
Submission
Audits
Regulatory requirements
Who can Benefit:
Regulatory and Quality Assurance associates/specialists
Manufacturing plants scheduled for inspections or audits by their customers or regulatory agencies
University students
Companies planning to file their products apart from home of origin

Use For Registration:
http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500381?expDate=Worldconferencecalendar.com