Module 12 Presentations

Challenges in creation & maintenance of current Product Information (PI)

10 Key challenges for Industry

The creation and maintenance of Product Information within a pharmaceutical company is a crucial aspect of drug development, regulatory and marketing. It involves numerous departments and stages . Quality control and regulatory compliance are crucial, as PI must align with the regulations set forth by governing bodies.

1.

Regulatory Compliance

2.

Language and Translations

3.

Readability

Regulatory

4.

Label Design

Marketing

Labelling

5.

Complexity of Data

6.

Integration with Packaging

Medical

7.

Availability of medicines

Legal

ePI

8.

Sustainability

9.

Falsified medicines

IT

Clinical

10. Patient centricity

Quality

The Organisation for Professionals in Regulatory Affairs