The FDA Drug Approval Process (London, United Kingdom - September 13-14, 2018)

  • ID: 4435282
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: September 13-14, 2018
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A comprehensive overview of FDA procedures, requirements for marketing authorizations and recent developments affecting the drug approval process in the US               
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      This seminar, by a US lawyer with over 40 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.

Gain an understanding of topics such as:

  • Structure and functions of the FDA
  • General regulatory requirements
  • Regulation of preclinical and clinical research
  • New drug application process
  • Biologics (including biosimilars)
  • Generic drugs
  • OTC drugs

Why you should attend

  • Structure and functions of the FDA
  • Historical background
  • General regulatory requirements
  • Regulation of preclinical and clinical research
  • New drug application process
  • Biologics (including biosimilars)
  • Generic drugs
  • OTC drugs
  • Special issues

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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Programme Day one


Structure and functions of the Food and Drug Administration

Historical background of US drug approval requirements

General regulatory requirements for drugs

  • Drug definition (drugs versus cosmetics, foods, biologics and medical devices)
  • Labelling rules
  • Patient information requirements
  • Good manufacturing practice regulations
  • Establishment registration and product listing

Regulation of pharmaceutical research

Preclinical research

  • Good laboratory practice
  • Guidelines for toxicity testing and special studies
  • ICH guidelines

Clinical Research

  • The investigational new drug (IND) application
  • Content
  • Procedure for FDA review
  • Clinical holds
  • Good Clinical Practice
  • Responsibilities of sponsors and monitors
  • Responsibilities of investigators
  • Transfer of responsibilities to contract research organisations (CROs)
  • Informed consent and institutional review boards (IRBs)
  • FDA guidelines for clinical studies
  • ICH guidelines
  • Expanded access programs, including treatment INDs
  • FDA enforcement programmes
  • Clinical site inspections
  • Disqualification of investigators
  • Other

Programme Day two

The new drug application (NDA) process

When an NDA is required

Content of NDAs

  • Electronic submissions

Requirements for approval

  • Safety
  • Effectiveness
  • Acceptance of foreign clinical data
  • Manufacturing, chemistry and controls
  • Labelling
  • Other

Procedures for review of NDAs

  • User fees
  • PDUFA commitments
  • Acceptance for filing
  • 74-day letter
  • Review priorities
  • Divisional review
  • Mid-cycle meetings
  • Amendments to pending applications
  • Advisory committees
  • Action letters and approvals
  • Dealing with a complete response letter
  • Dispute resolution procedures
  • Ombudsman
  • Informal appeals
  • Administrative hearings and judicial review
  • Accelerated approval, fast track and breakthrough status
  • Preapproval inspections
  • Review of initial promotional materials

Phase 4 studies, REMs and other post-market requirements

Supplemental NDAs

  • Labelling changes, new indications
  • Changes-being-effected (CBE) supplements
  • Manufacturing and formulation changes

Annual reports

Special issues

Safety reporting

  • Preclinical studies
  • Clinical studies
  • Post-marketing safety reports
  • Field alert reports and biological product deviation
  • reports

Biological products, including biosimilars

  • Abbreviated new drug applications (ANDAs)
  • General requirements
  • Bioequivalence issues
  • Data exclusivity and patent linkage

Over-the-counter drugs (including switches)
Orphan drugs

  • Designation procedures
  • Market exclusivity

Incentives for Paediatric Studies

Incentives for drugs to treat resistant microorganisms (GAIN Act)

Drug imports and exports

Freedom of Information Act

Recent developments including 21st Century

Cures proposals

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  • Andrew Willis Mr Andrew Willis,
    Consultant ,

    Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants.

    He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs.

    He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.

    He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

    Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.

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This meeting will be especially helpful for persons responsible for preparing US registration documents (INDs, NDAs, biologics licence applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The seminar will emphasise issues of interest to innovative manufacturers, but will also deal with issues relating to generic drugs and over-the-counter drugs.

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Rembrandt Hotel
11 Thurloe Pl,
United Kingdom


The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

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