- Sales & Marketing:
The impact of legislative changes, economic turmoil and an increase in competition from generics and biosimilars is forcing change in the pharmaceutical industry. In an increasingly crowded marketplace, there is pressure to ensure that sales force effectiveness is maximized, and the correct sales and marketing strategy implemented.
The success factors that determine an effective sales and marketing strategy depend on the area of practice. It is important to draw a distinction between traditional physician or prescriber visits, and more senior level market access discussions with payers and healthcare providers. The most effective strategy to pursue will depend on what kind of audience is being targeted.
- Distribution:
A channel strategy is a systematic, well-thought-through and integrated approach to these elements, considering channel components as a whole, and thinking through how they link to achieve an end goal.
In many companies, individual teams plan and organise channel activities but with a tactical focus, in isolation of overall brand goals and other tactics.
To appreciate the need for systematic channel strategies, let's consider an example: a new product
The product is only used by experts and has a risk management plan, so supply needs to be limited to key centres/hospitals. Patient persistence may be a key issue so a patient support programme may be needed. Finally, there is a significant price difference across Gulf countries, which may result in product diversion and shortages.
Each of the channel components therefore is relevant. The different goals might be achieved through working with a single specialty service provider rather than separate sales channels and suppliers.
Regulatory Affairs:
Pharmaceuticals, Veterinary medicines, Medical Devices, Herbal, Food Supplements,and Cosmeceuticals – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science companies ensure that their companies comply with all of the regulations and laws concerning their business.
The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. 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.
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.
Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs’ department.
Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role, for example, by considering the best processes to follow and enabling structured interaction with regulatory authorities. Regulatory Affairs is driven by good science and accordingly nothing remains static.
Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targets and key claims have to be reviewed and adapted to regulatory guidelines and regulations.
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