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.

The global Active Pharmaceutical Ingredients Market is expected to reach USD 205.51 billion by 2020 from USD 150 billion in 2015, at a CAGR of 6.5% during the forecast period. Factors such as the increasing incidence of life style and age related diseases, Increasing prevalence of cancer across the world, Technological advancements in the APIs Manufacturing, Emerging markets for biosimilar and increasing scope for Highly potent active ingredients are driving market growth. On the other hand, stringent regulatory requirements and global economic recession may restrict market growth.October 2015   $ 4650 selected

  • Global regulatory affairs organization
  • Role of global regulatory affairs
  • Key regulatory functions and activities
  • Global regulatory strategy
  • Global regulatory agency interactions

Related Conference of Regulation and Global Regulatory Affairs

Januray 19 2016

Basics of Pharmaceutical Regulatory Affairs

London UK
January 17-19 2016

Global Best Practices Conference

Dallas USA
January 28-29 2016

PCC 2016 - CBI s 13th Annual Pharmaceutical Compliance Congress

Alexandria USA
February 17-18 2016

Regulatory Strategy for Established Active Substances

Chesham UK
February 24-28 2016

Basics of Medical Devices Regulatory Affairs

London UK
February 4-5 2016

2nd Annual Food Labeling Evolving Regulatory Compliance Conference

Arlington USA
March 28-31 2016

Pharmaceutical regullatory summit 2016

Shanghai China
March 3-4 2016

Marketing Pharmaceuticals 2016

North Bethesda USA
28-Apr-16

Basics of Pharmaceutical Regulatory Affairs

London UK
April 13-15 2016

The US Regulatory Environment

Chesham UK
April 28-30 2016

Basics of Pharmaceutical Regulatory Affairs

London UK
May 18-19 2016

CRED Clinical Trials

London UK
May 21 - 24 2017

6th Pharmaceutical Sciences World Congress PSWC 2017

Stockholm Sweden
May 21-22 2016

World Health Professions Conference on Regulation 2016

Geneva Switzerland
June 16-18 2016

CRED SmPC Patient Information Leaflet Labelling

London UK
June 6-8 2016

CRED Variations

London UK
14-Jul-16

Basics of Pharmaceutical Regulatory Affairs

London UK
August 28-September 01 2016

World Congress of Pharmacy and Pharmaceutical Sciences 2016

Buenos Aires Argentina
August 8-9 2016

ICPRA 2016 18th International Conference on Pharmaceutical Regulatory Affairs

Venice Italy

Regulation and Global Regulatory Affairs Conference Speakers

Recommended Sessions

Related Journals

Are you interested in